Bone material removal device and a method for use thereof

ABSTRACT

A bone material removal device, including a tubular element comprising a proximal end and a distal end, a shaft received within the tubular element and comprising a proximal end and a distal end, a cutting tooth movably coupled to the distal end of the shaft and a shaft displacement actuator at the proximal end of the tubular element rotatably coupled to the shaft, wherein at least partial rotation of the actuator in a first direction brings the cutting tooth to travel from a closed retracted position to an open extended position.

RELATED APPLICATIONS

This application is a Continuation of PCT Patent Application No.PCT/IL2017/050170, having International filing date of Feb. 10, 2017,which claims the benefit of priority under 35 USC § 119(e) of U.S.Provisional Patent Application Nos. 62/294,108 filed on Feb. 11, 2016;62/336,715 filed on May 15, 2016; 62/352,184 filed on Jun. 20, 2016;62/360,434 filed on Jul. 10, 2016 and 62/436,243 filed on Dec. 19, 2016.

PCT Patent Application No. PCT/IL2017/050170 is also related to U.S.Provisional Patent Application No. 62/144,991 filed on Apr. 9, 2015.

The contents of the above applications are all incorporated by referenceas if fully set forth herein in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to boneremoval tools and more particularly, but not exclusively, to tools thatchange an effective diameter of a bore in bone.

It is known that during various arthroscopic procedures drilling of abore is required within a bone of a patient. In many occasions the boremay need to have portions having various diameters. Enlarged diametersmay be needed for one or more surgical procedures such as, for example,insertion of an anchor, administration of a drug or biologicals,insertion of a graft and insertion of an implant in AVN treatmentprocedures.

In other examples, in various arthroscopic procedures e.g., rotator cuffrepair and hip labrum replacement, an anchor is inserted into the bonein order to reattach injured tissue.

Different drilling tools are employed in order to drill a bore havingpredetermined dimensions.

Drilling tools are also used for insertion of biological material orproviding for bone bleeding to induce cartilage healing.

SUMMARY OF THE INVENTION

The present invention in some embodiments seeks to provide an improvedbone material removal device.

There is thus provided in accordance with some embodiment of the presentinvention a bone material removal device, including a tubular elementarranged along a longitudinal axis and comprising a proximal end and adistal end; a rotating body operatively attached to the proximal end ofthe tubular element and comprising an inner threading; a shaft elementdisposed within the tubular element and comprising a threaded portionengageable with the inner threading; a cutting tooth operativelypivotably connected to the shaft element; the shaft element ispositionable in a proximal operative orientation causing the cuttingtooth to assume a closed operative orientation; and the shaft element ispositionable in a distal operative orientation, upon axial displacementof the threaded portion over the inner threading, causing the cuttingtooth to assume an open operative orientation.

Preferably, the shaft element is operatively connected to the tubularelement by an indicating pin. Further preferably, the tubular elementhas a guiding slot configured to receive the indicating pin therein andallow axial movement of the indicating pin therealong. Additionally, theindicating pin is positioned in a proximal position when the shaftelement is positioned in the proximal operative orientation and theindicating pin is positioned in a distal position when the shaft elementis positioned in the distal operative orientation.

In accordance with some embodiments of the present invention, a methodof drilling a varying diameter bore, including the steps of: providing acannula comprising a cannula lever; providing a bone material removaldevice comprising a drilling tip and a selectably openable cuttingtooth; insert the bone material removal device into the cannula; formsan initial bore in a bone of a patient while pushing said drilling tipinto a bone of a patient in a distal direction and rotating the bonematerial removal device in a first direction; pressing the cannula leverin order to enable engagement between the cannula lever and at leastpart of the bone material removal device; reversing the drillingrotational direction to a second direction, which is opposite to thefirst direction, thus opening the cutting tooth; forms an undercut borein the bone of the patient by the cutting tooth, while pulling the bonematerial removal device in a proximal direction and rotating the bonematerial removal device in the second direction.

In accordance with some embodiments of the present invention, a bonematerial removal device, including a tubular element arranged along alongitudinal axis and comprising a proximal end and a distal end, arotating body operatively attached to the proximal end of the tubularelement and comprising an inner threading, a shaft element disposedwithin the tubular element and comprising a threaded portion engageablewith the inner threading, a cutting tooth operatively engageable withthe shaft element, the shaft element is positionable in a proximaloperative orientation causing the cutting tooth to assume a closedoperative orientation and the shaft element is positionable in a distaloperative orientation, upon axial displacement of the threaded portionover the inner threading, causing the cutting tooth to assume an openoperative orientation.

Preferably, the cutting tooth includes at least one leaf spring portionconfigured for biasing the cutting tooth to the closed operativeorientation. Further preferably, the shaft element is configured toexert force on the at least one leaf spring portion for urging thecutting tooth to the open operative orientation.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including a tubularelement including a proximal end and a distal end, a shaft receivedwithin the tubular element and including a proximal end and a distalend, a cutting tooth movably coupled to the distal end of the shaft anda shaft displacement actuator at the proximal end of the tubular elementrotatably coupled to the shaft at least partial rotation of the actuatorin a first direction brings the cutting tooth to travel from a closedretracted position to an open extended position. According to someembodiments, the actuator is activated manually and/or with a tool andincludes a first portion fixedly attached to the shaft and a secondportion rotatably coupled to the first portion. According to someembodiments of the invention, the actuator is rotatable about a longaxis of the shaft.

According to some embodiments of the invention the actuator isconfigured to rotate in a second opposite direction and bring thecutting tooth to travel from the open extended position to the closedretracted position and each increment of rotation of the actuatorcorresponds to an increment of travel of the cutting tooth between theopen extended position and the closed retracted position. 1 the actuatoris

According to some embodiments of the invention the device also includesan indicator indicating a degree of cutting tooth extension at any pointof rotation of the actuator. According to some embodiments, the actuatorblocks back pressure generated during operation.

According to some embodiments of the invention the actuator isconfigured to be partially rotated to set the cutting tooth at apredetermined position between the open extended position and the closedretracted position. According to some embodiments, the actuator includesa rotatable coupling including at least one slot in a wall of thetubular element proximal end, the slot having a longitudinal axis, theaxis being at an angle between 10 and 40 degrees in respect to theshaft.

According to some embodiments of the invention the tubular elementproximal end is attached to the shaft via a pin-in-slot coupling.According to some embodiments, the angle determines the ratio of axialdisplacement of the shaft in respect to amount of rotation of theactuator. According to some embodiments, the slot includes an at leastpartially spiral geometry and extends the full thickness of the tubularelement wall. According to some embodiments the coupling includes athreaded portion at the proximal end of the shaft interthreaded with athreaded portion of the actuator.

According to some embodiments of the invention the actuator includes atleast one eccentric rotatable mass. According to some embodiments, therotatable eccentric mass includes a flywheel.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including:a tubularelement including a proximal end and a distal end, a shaft receivedwithin the tubular element and including a proximal end and a distalend;

a cutting tooth movably coupled to at least one of the tubular elementand the distal end of the shaft and wherein displacement of the shaftaxially distally relative to the tubular element brings the cuttingtooth to travel from a closed retracted position to an open extendedposition in which at least a portion of the cutting tooth extends in aradial direction beyond an outside surface of the tubular element.

According to some embodiments of the invention displacement of the shaftaxially proximally relative to the tubular element brings the cuttingtooth to travel from the open extended position to a closed retractedposition at least partially within the tubular element.

According to some embodiments of the invention the shaft is configuredto be axially incrementally displaced relative to the tubular elementand bring the cutting tooth to pivot about a hinge and travelincrementally from the open extended position to the closed retractedposition and vice versa. According to some embodiments of the inventionthe cutting tooth is configured to be set at any point between the openextended position and the closed retracted position and vice versa thepoint determines a degree of extension of the cutting tooth and adiameter of an undercut created thereby.

According to some embodiments of the invention the distal end of thetubular element includes a slot and wherein the cutting tooth travelsradially outwards and inwards via the slot and the cutting tooth pivotsabout a hinge to travel from the closed retracted position to the openextended position beyond an outer surface of the tubular element.

According to some embodiments of the invention the cutting toothincludes at least one resilient portion and engages the tubular elementvia the resilient portion. According to some embodiments the cuttingtooth engages the distal end of the tubular element via the resilientportion of the cutting tooth the resilient portion exerts constant biasin a radially inward direction that resists outward radial extension ofthe cutting tooth.

According to some embodiments of the invention the cutting toothincludes at least one leaf spring portion configured for biasing thecutting tooth to the closed operative orientation. According to someembodiments the cutting tooth includes a base and a resilientlycantilevered arm supporting a cutting edge. According to someembodiments, the cantilevered arm is arced radially inwards to interferewith a path of axial distally displacement of the shaft.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including a tubularelement including a proximal end and a distal end, a shaft receivedwithin the tubular element and including a distal tapered end, a shaftdisplacement actuator rotatably coupled to the tubular element proximalend and movably coupled to the shaft at least partial rotation of theactuator displaces the shaft axially, a cutting tooth including a baseand a resiliently cantilevered arm supporting a cutting edge, thecantilevered arm is arced radially inwards to interfere with a path ofaxial distally directed displacement of the shaft and wherein axialdistally directed displacement of the shaft urges the tapered distal endunder the radially inwards arced cantilevered arm forcing the armradially outwardly and bringing the cutting tooth cutting edge to extendradially outwards beyond a surface of the reaming tubular element.According to some embodiments of the invention the arced radiallyinwards position includes a resting state of the cantilevered arm,forcing the arm radially outwardly places the arm in a loaded-stressedposition. According to some embodiments of the invention axialproximally displacement of the shaft withdraws the tapered distal endproximally from under the cantilevered loaded-stressed arm bringing thearm to return to its rest unstressed position withdrawing the cuttingtooth cutting edge into the tubular element. According to someembodiments the cutting tooth travels radially against bias exerted by aresilient attachment of the cutting tooth to the tubular element.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including a tubularelement including a proximal end and a distal end, a shaft receivedwithin the tubular element and including a proximal end and a distalend, a shaft displacement actuator at the proximal end of the tubularelement rotatably coupled to the shaft at least partial rotation of theactuator second portion displaces the shaft axially, a cutting toothmovably coupled to at least one of the tubular element and the shaft andpositioned in the tubular element distal end to interfere with a path ofaxial displacement of the shaft and wherein at least partial rotation ofthe actuator in a first direction displaces the shaft axially distallyrelative to the tubular element, the axially displaced shaft, beingengaged with at least a portion of the cutting tooth, brings the cuttingtooth to travel from a closed retracted position to an open extendedposition in which at least a portion of the cutting tooth extends in aradial direction beyond an outside surface of the tubular element.

According to some embodiments of the present invention axial proximaldisplacement of the shaft brings the cutting tooth to rotate and moveradially inwards.

According to some embodiments the cutting tooth includes at least oneresilient portion and is resiliently attached to the distal end of thetubular element via the resilient portion of the cutting tooth, theresilient portion exerts constant bias in a radially inward directionthat resists outward radial extension of the cutting tooth. According tosome embodiments the shaft is configured to disengage the cutting toothand bring the cutting tooth to move inwardly to the closed retractedposition tubular element.

According to some embodiments, the device also includes a cannula bodyhaving a bore extending throughout the length of the cannula configuredto rotatingly receive at least a portion of the tubular element.According to some embodiments the cannula body includes a leverincluding the break at one end and movably coupled at a second end tothe cannula body, the break configured to generate friction and stoprotation of the tubular element when the lever is pressed down and urgesthe break against the tubular element that stops rotation of the tubularelement inside the bore when actuated.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including a tubularelement including a proximal end and a distal end, a shaft receivedwithin the tubular element and including a proximal end and a distalend, a shaft displacement actuator rotatably coupled to the tubularelement proximal end and including an eccentric rotatable mass thatmovably couples the tubular element to the shaft via pins configured totravel along a slot in a wall of the tubular element, the slot beingangled between 10 and 40 degrees in respect to the shaft at leastpartial rotation of the eccentric rotatable mass in a first directioneffects a force that moves the pins within the slot from a firstposition to a second position and brings the cutting tooth to travelfrom a closed retracted position to an open extended position.

According to some embodiments, the actuator and eccentric rotatable massare configured to rotate in a second direction opposite to the firstdirection and to effect a force in an opposite direction that moves thepins within the slot from the second position to the first position anddisplaces the shaft axially proximally relative to the tubular elementand brings the cutting tooth to travel from the open extended positionto the closed retracted position in which the cutting tooth is receivedwithin the tubular element. According to some embodiments, axialproximal displacement of the shaft brings the cutting tooth to moveradially inwards to the closed retracted position in which the cuttingtooth is received in its entirety inside the tubular element.

According to some embodiments, the distal end of the tubular elementincludes a slot and wherein the cutting tooth travels radially outwardsand inwards via the slot, the cutting tooth includes at least oneresilient portion and the eccentric rotatable mass includes a flywheel.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including a tubularelement arranged along a longitudinal axis and including a proximal endand a distal end, a rotating body operatively attached to the proximalend of the tubular element and including an inner threading, a shaftelement disposed within the tubular element and including a threadedportion engageable with the inner threading, a cutting tooth operativelypivotably connected to the tubular element, the shaft is positionable ina proximal operative orientation causing the cutting tooth to assume aclosed operative orientation; and the shaft causing the cutting tooth toassume an open operative orientation by assuming a distal operativeorientation.

According to some embodiments of the present invention, the shaftelement is operatively connected to the reamer element by an indicatingpin that indicates the degree of shaft displacement and extension of thecutting tooth. According to some embodiments the tubular element has aguiding slot configured to receive an indicating pin therein and allowmovement of the indicating pin within the slot and the indicating pin ispositioned in a proximal position when the shaft is positioned in theproximal operative orientation and the indicating pin is positioned in adistal position when the shaft is positioned in the distal operativeorientation.

According to an aspect of some embodiments of the present inventionthere is provided a method of drilling a varying diameter bore,including providing a cannula including a cannula lever, providing abone material removal device including a drilling tip and a selectablyopenable cutting tooth, inserting the bone material removal device intothe cannula, forming an initial bore in a bone of a patient whilepushing the drilling tip into a bone of a patient in a distal directionand rotating the bone material removal device in a first direction,pressing the cannula lever in order to enable engagement between thecannula lever and at least part of the bone material removal device,reversing the drilling rotational direction to a second direction, thusopening the cutting tooth and forming an undercut bore in the bone bythe cutting tooth, while pulling the bone material removal device in aproximal direction and continuing rotating the bone material removaldevice in the second direction. According to some embodiments of thepresent invention the device further includes a shaft displacementindicator

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including acylindrical tubular element arranged along a longitudinal axis andhaving a proximal end and a distal end an eccentric rotatable mass isoperatively engaged to the distal end, the cylindrical tubular elementhaving a cutting tooth wherein the cutting tooth is positioned in anormally inwardly deflected orientation and wherein the cutting tooth isradially outwardly deflected due to force exerted by the eccentricrotatable mass.

According to an aspect of some embodiments of the present inventionthere is provided a method of drilling a varying diameter bore,including providing a bone material removal device including a shaftincluding a drilling tip and a selectably openable cutting tooth at oneend received inside a tubular element and coupled to a rotatableactuator at a second end, rotating the actuator in a first direction anddisplacing the shaft axially proximally and withdrawing the cuttingtooth into the tubular element, forming a bore in a bone by rotating thedrilling tip in a first direction and urging the tip into the bone in adistal direction, stopping the drilling rotation;

reversing the drilling rotational direction to a second direction,opposite to the first direction, rotating the actuator in a seconddirection and bringing the cutting tooth from a closed retractedposition to an open extended position in which at least a portion of thecutting tooth extends in a radial direction beyond an outside surface ofthe device and continuing rotating and pulling the device proximally andforming an undercut bore in the bone.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including a tubularelement including a proximal end and a distal end, a shaft receivedwithin the tubular element and including a distal tapered end, a shaftdisplacement actuator rotatably coupled to the tubular element proximalend and movably coupled to the shaft at least partial rotation of theactuator displaces the shaft axially, a cutting tooth including a baseand a resiliently cantilevered arm supporting a cutting edge, thecantilevered arm is arced radially inwards to interfere with a path ofaxial distally displacement of the shaft and wherein axial distallydisplacement of the shaft urges the tapered distal end under theradially inwards arced cantilevered arm forcing the arm radiallyoutwardly and bringing the cutting tooth cutting edge to extend radiallyoutwards beyond a surface of the reaming tubular element.

According to some embodiments of the present invention the arcedradially inwards position includes a resting state of the cantileveredarm and forcing the arm radially outwardly places the arm in aloaded-stressed position. According to some embodiments axial proximallydisplacement of the shaft withdraws the tapered distal end proximallyfrom under the cantilevered loaded-stressed arm bringing the arm toreturn to its rest unstressed position withdrawing the cutting toothcutting edge into the tubular element. According to some embodiments ofthe present invention the cutting tooth travels radially against biasexerted by a resilient attachment of the cutting tooth to the tubularelement and axial proximal displacement of the shaft moves the slopedportion from with-under the angled surface of the cutting tooth.

According to some embodiments a distal end of the cantilevered arm isattached to the base portion and the arm is arced proximally radiallyinwards and the shaft rests on an inside surface of the tubular elementand supports the cantilevered arm and the cutting tooth.

According to some embodiments radially inwardly directed bias exerted onthe cutting tooth drives the cutting tooth radially inward into thelumen of the tubular element once the shaft has been withdrawn axiallyproximally.

According to an aspect of some embodiments of the present inventionthere is provided a bone material removal device, including a tubularelement including a proximal end and a distal end, a shaft receivedwithin the tubular element and including a distal sloping end, a cuttingtooth including a cutting edge, an angled surface on an opposite side tothe cutting edge corresponding to the angled surface of the distal endof the shaft and at least one slot oriented radially to the shaft andconfigured to slide along at least one pin fixedly attached to thetubular element and restricts movement of the cutting tooth to a radialdirection and wherein axial displacement of the shaft urges the slopeddistal end under the angled surface of the cutting tooth bringing thecutting tooth to travel radially and extend beyond the surface of thetubular element.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIG. 1 is a simplified exploded view illustration of a bone materialremoval device and a cannula assembly, constructed and operative inaccordance with some embodiments of the present invention;

FIG. 2 is a simplified exploded view illustration of the bone materialremoval device, constructed and operative in accordance with someembodiments of the present invention;

FIG. 3 is a simplified exploded view illustration of the cannulaassembly, constructed and operative in accordance with some embodimentsof the present invention;

FIG. 4 is a simplified pictorial illustration of a rotating element,forming part of the bone material removal device of FIG. 2;

FIG. 5 is a simplified pictorial illustration of a tubular element,forming part of the bone material removal device of FIG. 2;

FIG. 6 is a simplified pictorial illustration of a sleeve element,forming part of the bone material removal device of FIG. 2;

FIG. 7 is a simplified pictorial illustration of a shaft element,forming part of the bone material removal device of FIG. 2;

FIG. 8 is a simplified pictorial illustration of a tip element, formingpart of the bone material removal device of FIG. 2;

FIG. 9 is a simplified pictorial illustration of a hinge element,forming part of the bone material removal device of FIG. 2;

FIG. 10 is a simplified pictorial illustration of a cutting toothelement, forming part of the bone material removal device of FIG. 2;

FIG. 11 is a simplified pictorial illustration of a cannula body,forming part of the cannula assembly of FIG. 3;

FIG. 12 is a simplified pictorial illustration of a cannula lever,forming part of the cannula assembly of FIG. 3;

FIG. 13 is a simplified pictorial illustration of a cannula break,forming part of the cannula assembly of FIG. 3;

FIG. 14 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 2 shown in a closed operativeorientation and enlargements thereof;

FIG. 15 is a simplified sectional view illustration of the bone materialremoval device of FIG. 14 shown in the closed operative orientation andenlargements thereof, section view being taken along lines A-A in FIG.14;

FIGS. 16A & 16B is a simplified partial sectional view illustration ofthe bone material removal device and the cannula assembly of FIG. 1shown in the closed operative orientation partially inserted into a boneof as patient and an enlargement thereof;

FIG. 17 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 2 shown in an open operative orientationand enlargements thereof;

FIG. 18 is a simplified sectional view illustration of the bone materialremoval device of FIG. 17 shown in the open operative orientation andenlargements thereof, section view being taken along lines B-B in FIG.17;

FIGS. 19A and 19B is a simplified partial sectional view illustration ofthe bone material removal device and the cannula assembly of FIG. 1shown in the open operative orientation partially inserted into a boneof as patient and an enlargement thereof;

FIG. 20 is a simplified sectional enlargement illustration of the bonematerial removal device of FIG. 1 shown during removal from the bone ofthe patient;

FIG. 21 is a simplified flow chart illustrating the use of the bonematerial removal device with the cannula assembly of FIG. 1;

FIG. 22 is a simplified block diagram illustrating the method of usingthe bone material removal device and cannula assembly of FIG. 1;

FIGS. 23A-23C are three simplified plan view illustrations of a cuttingtooth element, forming part of the bone material removal device of FIG.2, constructed and operative in accordance with some embodiments of thepresent invention;

FIG. 24 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 2, constructed and operative inaccordance with some embodiments of the present invention, shown in aclosed operative orientation and a partial section view and anenlargement thereof;

FIG. 25 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 2, constructed and operative inaccordance with some embodiments of the present invention, shown in anopen operative orientation and a partial section view and an enlargementthereof;

FIG. 26A is a simplified assembled view illustration of a bone materialremoval device and a cannula assembly, constructed and operative inaccordance with still another embodiment of the present invention;

FIG. 26B is a simplified exploded view illustration of the bone materialremoval device of FIG. 26A;

FIG. 27 is a simplified pictorial illustration of a rotating element,forming part of the bone material removal device of FIG. 26B;

FIGS. 28 and 29 are pictorial illustrations of a shaft element, formingpart of the bone material removal device of FIG. 26B;

FIG. 30 is a simplified pictorial illustration of a sleeve element,forming part of the bone material removal device of FIG. 26B;

FIG. 31 is a simplified pictorial illustration of a proximal portion ofa tubular element, forming part of the bone material removal device ofFIG. 26B;

FIG. 32 is a pictorial illustration of a distal portion of the tubularelement, forming part of the bone material removal device of FIG. 26B;

FIG. 33 is a simplified pictorial illustration of a cutting toothelement, forming part of the bone material removal device of FIG. 26B;

FIG. 34 is a pictorial illustration of a cannula retaining element,forming part of the bone material removal device of FIG. 26B;

FIG. 35 is a simplified exploded view illustration of the cannulaassembly, constructed and operative in accordance with some embodimentsof the present invention;

FIG. 36 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 26B shown in a closed operativeorientation and enlargements thereof;

FIG. 37 is a simplified sectional view illustration of the bone materialremoval device of FIG. 36 shown in the closed operative orientation andenlargements thereof, section view being taken along lines A-A in FIG.36;

FIG. 38 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 26B shown in an open operativeorientation and enlargements thereof;

FIG. 39 is a simplified sectional view illustration of the bone materialremoval device of FIG. 38 shown in the open operative orientation andenlargements thereof, section view being taken along lines B-B in FIG.38;

FIGS. 40A and 40B are simplified sectional illustrations of the bonematerial removal device and the cannula assembly of FIG. 26A shown inthe closed operative orientation partially inserted into a bone of apatient and an enlargement thereof;

FIG. 41 is a simplified sectional view illustration of the bone materialremoval device of FIG. 26A shown in an open operative orientation andenlargements thereof;

FIG. 42 is a simplified sectional view illustration of the bone materialremoval device of FIG. 26A shown during removal from the bone of thepatient;

FIG. 43 is a simplified exploded view illustration of a bone materialremoval device and a cannula assembly, constructed and operative inaccordance with still another embodiment of the present invention;

FIG. 44 is a simplified exploded view illustration of the bone materialremoval device of FIG. 43, constructed and operative in accordance withsome embodiments of the present invention;

FIG. 45 is a simplified exploded view illustration of the cannulaassembly of FIG. 43, constructed and operative in accordance with someembodiments of the present invention;

FIG. 46 is a simplified pictorial illustration of a tubular element,forming part of the bone material removal device of FIG. 44;

FIG. 47 is a simplified pictorial illustration of a shaft element,forming part of the bone material removal device of FIG. 44;

FIG. 48 is a simplified pictorial illustration of a body crank element,forming part of the bone material removal device of FIG. 44;

FIG. 49 is a simplified pictorial illustration of a guiding element,forming part of the bone material removal device of FIG. 44;

FIG. 50 is a simplified pictorial illustration of a rotating element,forming part of the bone material removal device of FIG. 44;

FIG. 51 is a simplified pictorial illustration of a pin element, formingpart of the bone material removal device of FIG. 44;

FIG. 52 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 44 shown in a closed operativeorientation and enlargements thereof;

FIGS. 53A and 53B are respective plan view and section view illustrationof the bone material removal device of FIG. 44 shown in the closedoperative orientation;

FIG. 54 is a simplified assembled plan view illustration of the bonematerial removal device of FIG. 44 shown in an open operativeorientation and enlargements thereof;

FIGS. 55A and 55B are respective plan view and section view illustrationof the bone material removal device of FIG. 44 shown in the openoperative orientation;

FIGS. 56A and 56B are respective simplified pictorial and sectionalillustrations of a cannula body, forming part of the cannula assembly ofFIG. 45;

FIGS. 57A and 57B are respective simplified pictorial and sectionalillustrations of a cannula inner sleeve, forming part of the cannulaassembly of FIG. 45;

FIG. 58 is a simplified pictorial illustration of a cannula cover,forming part of the cannula assembly of FIG. 45;

FIGS. 59A and 59B are a simplified pictorial illustration of a cannulabreak, forming part of the cannula assembly of FIG. 45;

FIGS. 60A and 60B are a simplified planar and sectional viewillustrations of the cannula assembly of FIG. 45;

FIGS. 61A and 61B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 44and 45 shown in the closed operative orientation partially inserted intoa bone of a patient;

FIGS. 62A and 62B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 44and 45 shown in an open operative orientation partially inserted into abone of the patient;

FIGS. 63A and 63B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 44and 45 shown in the open operative orientation while an undercut iscreated within the bone of the patient;

FIGS. 64A and 64B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 44and 45 shown in the closed operative orientation following removal fromthe bone of the patient;

FIG. 65 is a simplified pictorial illustration of a bone materialremoval device, constructed and operative in accordance with someembodiments of the present invention;

FIG. 66 is a simplified pictorial illustration of a body crank element,forming part of the bone material removal device of FIG. 65;

FIGS. 67A, 67B and 67C are simplified pictorial illustration, end planview and a section view of an adjusting element, forming part of thebone material removal device of FIG. 65, section being taken along linesC-C in FIG. 67A;

FIG. 68 is a simplified pictorial illustration of a disc element,forming part of the bone material removal device of FIG. 65;

FIG. 69 is a simplified pictorial illustration of a nut element, formingpart of the bone material removal device of FIG. 65;

FIGS. 70A and 70B are respective plan view and section viewillustrations of the bone material removal device of FIG. 65 shown in apartially open operative orientation;

FIGS. 71A and 71B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 65and 45 shown in the closed operative orientation inserted into a bone ofa patient;

FIGS. 72A and 72B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 65and 45 shown in a first partially open operative orientation insertedinto a bone of the patient;

FIGS. 73A and 73B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 65and 45 shown in a second partially open operative orientation insertedinto a bone of the patient;

FIGS. 74A and 74B are simplified planar and sectional view illustrationsof the bone material removal device and the cannula assembly of FIGS. 65and 45 shown in a fully open operative orientation inserted into a boneof the patient.

FIG. 75 is a simplified exploded view illustration of a bone materialremoval device constructed and operative in accordance with someembodiments of the present invention;

FIG. 76 is a simplified pictorial side view illustration of a rotatingelement of the bone material removal device of FIG. 75;

FIG. 77 is a simplified pictorial side view illustration of anembodiment of a connecting tube of the bone material removal device ofFIG. 75;

FIG. 78 is a simplified pictorial side view illustration of anembodiment of a drill tube of the bone material removal device of FIG.75;

FIG. 79 is a simplified pictorial side view illustration of anembodiment of an activating rod of the bone material removal device ofFIG. 75;

FIGS. 80A and 80B are simplified two different side view illustrationsof an embodiment of a drilling tip of the bone material removal deviceof FIG. 75;

FIG. 81 is a simplified side view illustration of an embodiment of aneccentric mass portion of a shaft displacement actuator of the bonematerial removal device of FIG. 75;

FIGS. 82A and 82B are simplified respective pictorial and sectional viewillustrations of an embodiment of the bone material removal device ofFIG. 75 shown in a first closed operative drilling orientation;

FIGS. 83A and 83B are simplified pictorial and sectional viewillustrations of an embodiment of the bone material removal device ofFIG. 75 shown in a second open operative drilling orientation;

FIG. 84 is a simplified partial sectional view illustration of anembodiment of the bone material removal device of FIG. 75 shown in thefirst closed operative drilling orientation within the bone of apatient;

FIG. 85 is a simplified partial sectional view illustration of anembodiment of the bone material removal device of FIG. 75 shown in thesecond open operative drilling orientation within the bone of a patient;

FIG. 86 is a simplified partial sectional view illustration of anembodiment of the patient bone following removal of the bone materialremoval device.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to bonematerial removal tools and more particularly, but not exclusively, totools that change an effective diameter of a bore in bone.

A bone material removal device is disclosed herein, which isparticularly useful for drilling a bore with varying diameters within abone of a patient.

It is a particular feature of some embodiments of the present inventionthat the bone material removal device is useful for forming a cavity inthe bone for positioning a soft anchor and allow its expansion withinthe formed cavity volume, thus preventing removal of the anchortherefrom.

It is another particular feature of some embodiments of the presentinvention that the bone material removal device is also useful forforming a cavity inside the bone of a patient for retaining biologicalmaterial, such as medicament, therein and prevent from the material toleak outside of the formed cavity. Particularly, the bone materialremoval device is useful for forming a cavity for subchondral biologicsintroduction.

An aspect of some embodiments of the invention relates to a bonematerial removal device configured to drill a bore in bone andselectively expand the diameter of the bore to form an undercut and amechanism to control the diameter of the undercut. In some embodiments,the device comprises a shaft received within a tubular element. In someembodiments, the device comprises a cutting tooth movably coupled to adistal end of the shaft. In some embodiments, the device comprises ashaft displacement actuator at a proximal end of the tubular elementrotatably coupled to the shaft. In some embodiments, at least partialrotation of the actuator in a first direction brings the cutting toothto travel from a closed retracted position to an open extended position.

In some embodiments, the degree of rotation of the actuator correspondsto the degree of radial movement of the cutting tooth. In someembodiments, the actuator is configured to rotate incrementally andbring the cutting tooth to travel incrementally from a closed retractedposition to a radially extended position and vice versa. In someembodiments, the actuator is configured to rotate less than a maximalrange of rotation and set the cutting tooth at a degree of extensionbetween a closed retracted position and an open extended position. Insome embodiments, the degree of extension of the cutting tooth set bythe actuator defines a diameter of an expanded portion of the bore(e.g., undercut) to be made in the bone.

In some embodiments, the actuator is rotatingly coupled to the shaft. Insome embodiments, the actuator comprises a first portion fixedlyattached to the shaft and a second portion rotatably coupled to thefirst portion. In some embodiments, the actuator is rotatable about alongitudinal axis of the shaft.

In some embodiments, the actuator comprises a rotatable couplingcomprising at least one slot in a wall of a proximal end of the tubularelement. In some embodiments, the slot comprises a longitudinal axis,the axis being at an angle between 10 and 40 degrees in respect to theshaft. In some embodiments, the slot comprises a portion of apin-in-slot coupling that couples the tubular element proximal end tothe shaft. In some embodiments, the slot comprises at least a partialhelix. In some embodiments, the angle of the slot and/or the helixdetermines the ratio of axial displacement of the shaft in respect to adegree of rotation of the actuator.

In some embodiments, rotatable coupling comprises a threaded portion atsaid proximal end of the shaft interthreaded with a threaded portion ofthe actuator. In some embodiments, the actuator comprises at least oneeccentric rotatable mass. In some embodiments, the rotatable masscomprises an eccentric flywheel.

In some embodiments, the rotatable actuator blocks back pressuregenerated during operation.

An aspect of some embodiments of the invention relates to types ofcutting teeth of a bone material removal device configured to drill abore in bone and selectively expand the diameter of the bore to form anundercut in bone. In some embodiments, the device comprises a cuttingtooth positioned at a distal end of the tubular element. In someembodiments, the cutting tooth is positioned inside the tubular elementlumen so that to interfere with a path of axial displacement of theshaft. In some embodiments, the cutting tooth extends outward and isdrawn inward out of and into a lumen of the tubular element lumen via aslot in a wall of the element.

In some embodiments, the cutting tooth is movably coupled to the tubularelement.

In some embodiments, the coupling comprises a pin hinge and the cuttingtooth moves rotatively about the pin. In some embodiments, the couplingcomprises at least one pin-in-slot hinge in which at least one slot inthe cutting tooth blade is configured to slide along at least one pin.In some embodiments, the pin is fixedly attached to the tubular elementand restricts direction of movement (extension and retraction) of thecutting tooth.

In some embodiments, the pin restricts the movement of the cutting toothto radial movement in and out of the slot.

In some embodiments, the hinged coupling comprises a resilientattachment. In some embodiments, the resilient attachment is a leafspring. In some embodiments, the resilient attachment exerts constantbias in a radially inward direction. In some embodiments, the resilientattachment resists outward radial extension of the cutting tooth.

In some embodiments, the cutting tooth comprises a base and acantilevered arm supporting a cutting edge. In some embodiments, thecantilevered arm is arced distally to proximally radially inwards tointerfere with a path of axial distally displacement of the shaft. Insome embodiments, the distal end of the shaft is tapered. In someembodiments, axial distally displacement of the shaft urges the tapereddistal end of the shaft under the radially inwards arced cantileveredarm forcing the arm radially and bringing the cutting tooth cutting edgeto extend radially outwards beyond the surface of the tubular element.

In some embodiments, a portion of the distal end of the shaft is sloped.In some embodiments, the cutting tooth comprises an angled surface on anopposite side to the cutting edge of the blade, and corresponding to thesloped surface of the distal end of the shaft. In some embodiments, thecutting tooth travels radially against bias exerted by a resilientattachment of the cutting tooth to the tubular element. In someembodiments, radially inwardly directed bias exerted on the cuttingtooth drives the cutting tooth radially inward, into the lumen of thetubular element once the shaft has been withdrawn axially proximally.

An aspect of some embodiments of the invention relates to a bonematerial removal device comprising a shaft displacement actuatorconfigured to control and select the diameter of the undercut. In someembodiments, the actuator comprises a rotatable eccentric mass. In someembodiments, the rotatable eccentric mass comprises a flywheel. In someembodiments, the device comprises a tubular element that houses a shaftaxially movable within a lumen of the element. In some embodiments, therotatable eccentric mass movably couples the tubular element to theshaft via pins configured to travel along a slot in a wall of thetubular element. In some embodiments, the slot is angled in respect to along aspect of the shaft. In some embodiments, at least partial rotationof the rotatable eccentric mass in a first direction effects a forcethat moves the pins within the slot from a first position to a secondposition and displaces the shaft axially distally. In some embodiments,the shaft is displaced axially and distally against a bias of a spring.

An aspect of some embodiments of the invention relates to mechanismsthat enable an operator of a bone material removal device to selectivelyexpand a diameter of a bore to form an undercut in bone. In someembodiments, the device comprises a shaft received within a tubularelement. In some embodiments, the device comprises a cutting toothmovably coupled to a distal end of the shaft. In some embodiments, thedevice comprises a shaft displacement actuator at a proximal end of thetubular element rotatably coupled to the shaft.

In some embodiments, the device comprises at least one rotatingcomponent (e.g., the cutting tooth and/or the actuator) and at leastlinearly displaceable component (e.g., the cutting tooth and/or theshaft). In some embodiments, the actuator is configured to rotate andaxially displace the shaft that in turn rotates the cutting tooth. Insome embodiments, an actuator-shaft coupling is configured to convertrotational movement of the actuator into linear axial movement of theshaft. In some embodiments, a shaft-cutting tooth coupling is configuredto convert linear-axial movement of the shaft into rotational movementof the cutting tooth. In some embodiments, a shaft-cutting toothcoupling is configured to convert linear axial movement of the shaftinto radially directed displacement of the cutting tooth.

In some embodiments, the actuator is configured to rotate about thelongitudinal axis of the shaft. In some embodiments, a plane of rotationof the cutting tooth is angled in respect to the plane of rotation ofthe actuator. In some embodiments, the angle is 90 degrees. In someembodiments, the angle is between 0 and 180 degrees.

In some embodiments, the device comprises a shaft received within atubular element. In some embodiments, the shaft is axially displaceablewithin a lumen of the element. In some embodiments, the actuator isrotatably coupled to the tubular element proximal end and movablycoupled to the shaft so that at least partial rotation of the actuatordisplaces the shaft axially. In some embodiments, axial displacement ofthe shaft relative to the tubular element brings a cutting tooth at adistal end of the tubular element to travel from a closed retractedposition to an open extended position in which at least a portion of thecutting tooth extends in a radial direction beyond an outside surface ofthe tubular element to carve bone from a wall of the bore expanding thediameter of the bore.

In some embodiments, rotation of the actuator in the second directiondisplaces the shaft axially and proximally and brings the cutting toothto travel from an open extended position to a at least partially closedretracted position inside the lumen of the tubular element.

In some embodiments, the cutting tooth is movably coupled to at leastone of the tubular element and the shaft and positioned at a distal endof the tubular element such that to interfere with a path of axialdisplacement of said shaft. In some embodiments, the cutting toothcomprises a cutting edge and an angled surface on an opposite side tothe cutting edge.

In some embodiments, the shaft comprises a sloped distal end. In someembodiments, the angled edge of the cutting tooth corresponds to thesloped distal end of the shaft. In some embodiments, axial displacementof the shaft urges the sloped distal end under the angled surface of thecutting tooth bringing the cutting tooth to travel radially and extendbeyond the surface of the tubular element. In some embodiments, axialproximal displacement of the shaft moves the angled portion from withunder the angled surface of the cutting tooth.

Reference is now made to FIG. 1, which is a simplified perspective viewsimplified illustration of a bone material removal device and a cannulaassembly, constructed and operative in accordance with some embodimentsof the present invention.

As seen in the exemplary embodiment of FIG. 1, a bone material removaldevice 10000 comprises a shaft displacement actuator that comprises arotating element 102 configured to be rotatably attached to a tubularelement 104 (e.g., a reamer element or a drilling element) by a sleeve106. A tip element 108 is attached or integrally made with the tubularelement 104. A potential advantage of a rotating shaft displacementactuator is in that the actuator-shaft coupling prevents back pressureapplied axially in a proximal direction along shaft 130 do directlyaffect and displace the shaft displacement actuator proximally andchanging the setting to the cutting tooth during operation. Ashaft-rotating actuator coupling converts the displacement back forcesfrom axial forces applied proximally along the shaft to rotationalforces applied perpendicularly to the axial forces. Thus the rotatingactuator at least partially blocks the back pressure generated duringoperation as a reaction to pressure exerted during drilling. It is seenthat rotating element 102, tubular element 104, sleeve 106 and tipelement 108 are all arranged along a single mutual longitudinal axis109.

It is additionally seen in FIG. 1 that a cannula assembly 120 isconfigured to be mounted over the tubular element 104 and arranged alonglongitudinal axis 109. Cannula assembly 120 includes a cannula body 122and a cannula lever 124.

It is appreciated that the tubular element is preferably made of abiocompatible material, e.g., biocompatible metal.

Reference is now made to FIG. 2, which is a simplified exploded viewillustration of the bone material removal device 100, constructed andoperative in accordance with some embodiments of the present invention.

It is seen in the embodiment depicted in FIG. 2 that the rotatingelement 102 is configured to be attached to the tubular element 104 andretained by fixed attachment of sleeve 106 to the tubular element 104,such as, for example, by heat welding. The sleeve 106 enables freerotational movement of the rotating element 102 relative to the tubularelement 104.

It is noted, as will be described in detail hereinbelow, that therotating element 102 includes internal threading as explained in greaterdetail elsewhere herein. A longitudinal shaft 130 comprising a threadedportion 132 is configured to be at least partially inserted into thetubular element 104 and at least partially into rotating element 102,such that the threaded portion 132 of shaft 130 engages the internalthreading of the rotating element 102. The shaft 130 is configured to beconnected to the tubular element 104 by an indicating pin 134.

It is seen in embodiment in FIG. 2 that a hinge element 136 isconfigured to be rotatably attached at a first end by a pin 138 to anend of the shaft element 130 and at a second end to a cutting tooth 140via pin 142. The cutting tooth 140 is configured to be rotatablyattached to a tip element 108 via a pin 144.

Reference is now made to FIG. 3, which is a simplified exploded viewillustration of the cannula assembly 120, constructed and operative inaccordance with some embodiments of the present invention.

It is seen in the embodiment in FIG. 3 that the cannula assembly 120includes hollow cannula body 122, which is configured to be mounted overthe bone material removal device 100 and arranged along longitudinalaxis 109. Cannula assembly 120 further includes cannula lever 124, whichis configured to be pivotably attached to the cannula body 122.

It is seen in FIG. 3 that a cannula break 150 is fixedly attached tocannula lever 124. The cannula break 150 is configured to be partiallyinserted through an opening 158 in cannula body 122.

A cannula lever biasing element 152 is configured to be fixedly attachedto the cannula body 122 and configured to urge and return the cannulalever 124 to its initial, e.g., elevated position after it is presseddown. It is appreciated that cannula lever biasing element 152 can bemade of a resilient material and in some embodiments formed as a leafspring.

Reference is now made to FIG. 4, which is a simplified pictorialillustration of an exemplary embodiment of a rotating element 102, formspart of the bone material removal device 100 depicted in FIG. 2.

Rotating element 102 is a generally longitudinal hollow cylindricalintegrally made element comprising a proximal end 160 configured to beoptionally inserted into a power tool (not shown) and a distal end 162configured to be optionally inserted into the tubular element 104. Theterm “Proximal” as used herein when relates to position refers to aposition closest to an operator (e.g., surgeon). The term “Proximal” asused herein when relates to direction refers to a direction towards anoperator (e.g., surgeon). The term “Distal” as used herein when relatesto position refers to a position farthest from an operator (e.g.,surgeon). The term “Distal” as used herein when relates to directionrefers to a direction away from an operator (e.g., surgeon). A flange164 is disposed adjacent distal end 162, defining a distally facingshoulder 166 and a proximally facing shoulder 168. It is further seenthat an internal threading 170 is formed along at least part of thelength of rotating element 102.

Reference is now made to FIG. 5, which is a simplified pictorialillustration of an exemplary embodiment of a tubular element 104,forming part of the bone material removal device 100 depicted in FIG. 2.

Tubular element 104 is a generally longitudinal hollow cylindricalintegrally made element comprising a proximal end 172 configured to beattached to rotating element 102 and a distal end 174 configured to beattached to tip element 108 or integrally made therewith. Tubularelement 104 comprises a bore 176 throughout at least a portion of itslength, which is configured to receive and enclose shaft element 130. Insome embodiments, bore 176 extends throughout the entire length oftubular element 104.

An engagement surface 178 is located at the proximal end 172 forengagement with sleeve 106.

It is further seen in FIG. 5 that preferably two longitudinally orientedguiding slots 180 are formed on tubular element 104 adjacent proximalend 172. Guiding slots 180 extend along an axis, which is transverselydisposed with respect to longitudinal axis 109 and are preferablyaligned with each other. In some embodiments, tubular element 104guiding slots 180 are positioned diametrically opposed.

Reference is now made to FIG. 6, which is a simplified pictorialillustration of an exemplary embodiment sleeve element 106, forming partof the bone material removal device 100 shown, for example, in FIG. 2.

It is seen in FIG. 6 that the sleeve element 106 is a cylindrical hollowintegrally made element comprising a proximal bore 190 of a firstdiameter and a distal bore 192 of a second diameter, generally greaterthan the first diameter and a distally facing shoulder 194 definedtherebetween. In FIG. 6, inner circumference 196 defines proximal bore190.

Reference is now made to FIG. 7, which is a simplified pictorialillustration of an exemplary embodiment of a shaft element 130, thatforms part of the bone material removal device 100 as shown for examplein FIG. 2.

In FIG. 7 shaft element 130 is preferably longitudinal integrally madeelement comprising a proximal end with threaded portion 132 and a distalend 200 for partial insertion into the tip element 108. A through bore202 extending transversely with respect to longitudinal axis 109 islocated adjacent and slightly distally from threaded portion 132.

Through bore 202 is configured for insertion of positioning pin 134therethrough.

It is further shown in FIG. 7 that a recess 204 is formed at the distalend 200 of shaft element 130 and extends slightly longitudinallytherefrom. A bore 206 is also formed at the distal end 200 of shaftelement 130 and extends transversely with respect to recess 204. Therecess 204 and bore 206 are configured for attachment of the hingeelement 136 to shaft element 130.

Reference is now made to FIG. 8, which is a simplified pictorialillustration of an exemplary embodiment of a tip element 108, formingpart of the bone material removal device 100, as shown for example inFIG. 2.

As shown in FIG. 8 the tip element 108 is a preferably longitudinallyhollow element having a distal sharp drilling edge 210. The tip element108 can alternatively be integrally made with tubular element 104.

Preferably two or more longitudinal guiding slots 212 are formed on tipelement 108 adjacent drilling edge 210. Guiding slots 212 extend alongan axis, which is transversely disposed with respect to longitudinalaxis 109 and are preferably aligned with each other. In someembodiments, guiding slots 212 are positioned diametrically opposed.

Guiding slots 212 lead to a hollow 216 configured to at least partiallyaccommodate cutting tooth 140. A through bore 214 is formed through tipelement 108 and extends transversely with respect to guiding slot 212,bore 214 additionally extends transversely with respect to longitudinalaxis 109. The through bore 214 is utilized for insertion of an axle,acting as a pivotal axis P of cutting tooth 140.

Reference is now made to FIG. 9, which is a simplified pictorialillustration of an exemplary embodiment of a hinge element 136, formingpart of the bone material removal device 100 of FIG. 2.

Hinge element 136 comprises an integrally formed longitudinal elementhaving a proximal bore 220 for attachment of an axle enabling pivotalconnection between the hinge element 136 and the shaft element 130, anda distal bore 222 for attachment of an axle enable pivotal connectionbetween the hinge element 136 and cutting tooth 140.

Reference is now made to FIG. 10, which is a simplified pictorialillustration of cutting tooth element 140, forming part of the bonematerial removal device 100 of FIG. 2.

Cutting tooth element 140 comprises an integrally made element having asharp cutting edge 230.

A hook-like element 232 is formed on cutting tooth element 140 definingan aperture 234 for insertion of an axle therethrough enabling pivotalattachment of the cutting tooth element 140 with tip element 108.

Cutting tooth 140 further comprises a through bore 236 for insertion ofan axle e.g., pin 142 therethrough enabling pivotal attachment of thecutting tooth 140 to hinge element 136. In some embodiments, bore 236 ispositioned off-center, close to one edge of tooth 140. In someembodiments, pin 142, pivotly attaching tooth 140 to tip element 108acts as a selective stopper, stopping tooth 140 from axial displacementbut allowing movement in other directions, e.g., allowing cutting tooth140 to rotate about pin 142 when urged axially distally or pulledaxially proximally.

Reference is now made to FIG. 11, which is a simplified pictorialillustration of an exemplary embodiment of cannula body 122, that formsa part of the cannula assembly 120 e.g., the embodiment shown in FIG. 3.

Cannula body 122 is an integrally made hollow generally cylindricallongitudinal element, configured to be arranged along longitudinal axis109. Cannula body 122 comprises a through bore 240 extending alonglongitudinal axis 109. The cannula body 122 further defines an outergripping surface 242.

Cannula body 122 comprises a proximal end 244 and a distal end 246. Asshown in FIG. 11 a recess 248 is formed at the distal end 246 of cannulabody, the recess 248 configured for pivotal attachment of the cannulalever 124 thereto.

Generally two apertures 250 are disposed adjacent and slightlyproximally to distal end 248 of cannula body. Apertures 250 areconfigured for fixed attachment of cannula lever biasing element 152 tocannula body 122.

A recess 252 is formed in a location between proximal end 244 and distalend 246 and extends transversely with respect to longitudinal axis 109.Recess 252 intersects with bore 240.

Reference is now made to FIG. 12, which is a simplified pictorialillustration of an exemplary embodiment of cannula lever 124, that formsa part of the cannula assembly 120 e.g., as shown in FIG. 3.

It is seen in the embodiment shown in FIG. 12 that cannula lever 124 isan integrally formed element. In some embodiments, cannula lever 124 isgenerally L-shaped and comprises a longitudinal portion 260 and aconnection portion 262. Connection portion 262 comprises a bore 264 forinsertion of an axle therethrough to enable pivotable connection betweencannula lever 124 and cannula body 122.

Longitudinal portion 260 comprises generally two apertures 266 formedtherethrough for insertion of screws to enable fixed attachment ofcannula break 150 to cannula lever 124.

Reference is now made to FIG. 13, which is a simplified pictorialillustration of an exemplary embodiment of a cannula break 150, thatforms a part of the cannula assembly 120 e.g., as shown in FIG. 3.

The cannula break 150 comprises two apertures 182 (FIG. 3) for insertionof screws thereto and attachment with cannula lever 124. The cannulabreak 150 comprises a longitudinally extending surface 270 forengagement with shaft element 130. In some embodiments, surface 270 isconcave.

Reference is now made to FIG. 14, which is a simplified plan viewillustration of an exemplary embodiment of the bone material removaldevice 100 (e.g., as shown in FIG. 2) shown in a closed operativeorientation and enlargements thereof and to FIG. 15, which is asimplified sectional view illustration of the bone material removaldevice 100 embodiment depicted in FIG. 14 shown in a closed operativeorientation and enlargements thereof, section view being taken alonglines A-A in FIG. 14. Reference is additionally made to FIGS. 16A and16B, which are simplified partial sectional view illustration of anexemplary embodiment of the bone material removal device 100 and thecannula assembly 120 (e.g., as depicted in FIG. 1) shown in a closedoperative orientation partially inserted into a bone of a patient and anenlargement thereof.

As shown in the embodiment illustrated in FIGS. 14-16B bone materialremoval device 100 is positioned in a closed operative orientation, inwhich the cutting tooth 140 is closed, accommodated inside hollow 216and does not protrude radially through guiding slot 212. In this closedorientation, a diameter of a bore formed in a bone while drilling isequal to the outer diameter of tip element 108.

As shown in FIG. 14 tubular element 104 is rotatably connected torotating element 102 by means of sleeve element 106, such that a flange164 of rotating element 102 lies sandwiched between and against distallyfacing shoulder 194 of sleeve 106 and proximal end of tubular element104. The surface of bore 190 of sleeve element 106 abuts connectingportion 178 of tubular element 104 and allows rotation of tubularelement 102.

It is a particular feature of some embodiments of the present inventionthat threaded portion 132 of shaft element 130 is threadably attached toan inner threading 170 of rotating element 102. The shaft element 130 isdisposed at its proximal operative orientation in this closed positionand is attached to the tubular element 104 by means of indicating pin134.

It is a particular feature of some embodiments of the present inventionthat the indicating pin 134 is positioned at the forward end of guidingslot 180 of tubular element 104 when the bone material removal device ispositioned at the closed operative orientation, since the indicating pin134 is inserted into bore 202 of shaft element 130, which is disposed atthe proximal operative orientation at this stage.

It is further particularly seen in FIGS. 15 and 16B that the shaftelement 130 is pivotably connected to hinge element 136, which in turnis pivotably connected to cutting tooth 140.

It is a particular feature of some embodiments of the present inventionthat when the shaft element is positioned in its proximal operativeorientation, the cutting tooth 140 is fully enclosed within the tubularelement 104 hollow 216 and does not protrude through guiding slot 212.

It is particularly shown in FIGS. 16A and 16B that bone material removaldevice 100 is inserted into bore 240 of cannula body 122, which formspart of the cannula assembly 120. It is particularly seen in FIG. 16Athat the cannula lever 124, which is pivotably connected to the cannulabody 122, is not pressed at this operative orientation, thus cannulalever biasing element 152 is positioned at an unstressed orientation andthe cannula break 150 is not in contact with the tubular element 104.

As illustrated in FIGS. 16A and 16B, an initial bore 300 of a firstdiameter is formed in the bone of the patient while drilling with thebone material removal device 100 positioned in its closed operativeorientation. It is noted that this initial drilling is provided whilethe rotating element 102 is rotated in a first rotational direction, inthis exemplary embodiment, in a clockwise direction.

While the rotating element 102 and the tubular element 104 rotate in aclockwise rotational direction, the sharp drilling tip 210 of tip 108engages the bone of the patient and creates initial bore 300 therein.

Reference is now made to FIG. 17, which is a simplified plan viewillustration of an exemplary embodiment of the bone material removaldevice 100 e.g., as depicted in FIG. 2 shown in an open operativeorientation and enlargements thereof and to FIG. 18, which is asimplified sectional view illustration of the embodiment of the bonematerial removal device 100 shown in FIG. 17 shown in the open operativeorientation and enlargements thereof, section view being taken alonglines B-B in FIG. 17. Reference is additionally made to FIGS. 19A and19B, which is a simplified partial sectional view illustration of anexemplary embodiment of the bone material removal device 100 and thecannula assembly 120 e.g., as depicted in FIG. 1 shown in the openoperative orientation partially inserted into a bone of as patient andan enlargement thereof and to FIG. 20, which is a simplified sectionalenlargement illustration of the bone material removal device 100 of FIG.1 shown during removal from the bone.

As shown in the embodiments depicted in FIGS. 17-20, the bone materialremoval device 100 is positioned in an open operative orientation, inwhich the cutting tooth 140 is open and protrudes through guiding slot212, thus the diameter of the bore formed in the bone of the patientwhile drilling in the open operative orientation of the bone materialremoval device 100 is greater than the outer diameter of tip element108.

It is a particular feature of some embodiments of the present inventionthat threaded portion 132 of shaft element 130 is threadably coupled toinner threading 170 of rotating element 102. The shaft element 130 isdisposed at its distal operative orientation in this open position andis attached to the tubular element 104 by means of indicating pin 134.

It is a particular feature of some embodiments of the present inventionthat the indicating pin 134 is positioned at the distal end of guidingslot 180 of tubular element 104 when the bone material removal device ispositioned at the open operative orientation, since the indicating pin134 is inserted into bore 202 of shaft element 130, which is disposed atthe distal operative orientation at this stage.

It is further particularly shown that the shaft element 130 is pivotablyconnected to hinge element 136, which in turn is pivotably connected tocutting tooth 140.

In some embodiments, at least a portion of cutting tooth 140 is disposedin the path of, and interferes with, axial displacement of shaft element130. Axial displacement of shaft element 130 distally urges hingeelement 136 against tooth 140 axially. Pin 142 acts as a selectivestopper, stopping tooth 140 from displacing axially but allowingmovement in other directions, e.g., allowing cutting tooth 140 to rotateabout pin 142 when urged axially distally and extend radially in respectto shaft 130. It is a particular feature of some embodiments of thepresent invention that when the shaft element is positioned in itsdistal operative orientation, the cutting tooth 140 is pivoted aboutaxis 214 to extend radially outwardly, and preferably generallytransversely to longitudinal axis 109 and to protrude through guidingslot 212 of tip element 108.

It is particularly seen in FIGS. 17-20 that bone material removal device100 is inserted into bore 240 of cannula body 122, which forms part ofthe cannula assembly 120.

It is particularly seen in FIGS. 18 and 19A that the cannula lever 124,which is pivotably connected to the cannula body 122, is pressed at thisoperative orientation, thus cannula lever biasing element 152 ispositioned at a deflected stressed orientation and the cannula break 150is engaged with the tubular element 104 to create friction force betweenthe cannula lever 124 and the tubular element 104 in order to stop therotational movement of the tubular element 104 to enable changing thedrilling rotational direction.

It is seen in FIGS. 17-20 that an undercut bore 302 is formed over theinitial bore 300, undercut bore 302 having a second diameter, which isgreater than the first diameter while drilling with the bone materialremoval device 100 positioned in its open operative orientation. It isnoted that this undercut bore drilling is provided while the rotatingelement 102 is rotated in a second rotational direction, in thisexemplary embodiment, in a counter-clockwise direction.

It is a particular feature of some embodiments of the present inventionthat once the cannula lever 124 is pressed and the rotation of thetubular element 104 is momentarily stopped, the rotational direction ofthe drilling can be reversed, thus causing the threaded portion 132 ofshaft element 130 to unthread i.e., unscrew (turn in a directionopposite to the initial direction of threading) from internal threading170 of rotating element 102. Since indicating pin 134 attaches the shaftelement 130 to the guiding slot 180 of the tubular element 104, rotationof the shaft element 130 is prevented and this unthreading causes axialdisplacement of the shaft element 130 in a distal direction. The extentof longitudinal displacement of the shaft element 130 depends on thelength of guiding slot 180, thus during the axial displacement of shaftelement 130 in a distal direction, the indicating pin 134 is displacedalong the guiding slot 180 from its proximal end to its distal end.

It is a further particular feature of some embodiments of the presentinvention that axial longitudinal displacement of shaft element 130distally urges the hinge element 136 to pivot about axis 220, thus urgespivoting of axis 222 of hinge element 136, which in turn urges pivotingof cutting tooth 140 about axis 221 of pin 142 and causes the cuttingtooth 140 to pivot radially e.g., from its initial orientation andprotrude through guiding slot 212 of tip element 108.

While the rotating element 102 and the tubular element 104 rotate in acounter-clockwise rotational direction, the cutting edge 230 of cuttingtooth 140 engages the bone of the patient and creates undercut bore 302therein. It is noted that the cannula lever 124 may be released once thedrilling rotational direction is reversed and the bone material removaldevice 100 can be advanced and retracted in and out of the bone of thepatient in order to create the desired length of undercut bore 302.

It is appreciated that in order to return to the closed operativeorientation of the bone material removal device 100, cannula lever 124has to be pressed to stop the rotation of drill element 130 and thedrilling rotational directional has to be reversed in order to urge theshaft element 130 to be displaced axially in a proximal direction, thusaxially pulling hinge element 136 which in turn axially pulls cuttingtooth 140 bringing tooth 140 to pivot about pin 142 such that tooth 140is fully drawn into hollow 216 and fully enclosed within tip element108. At this stage, the bone material removal device can be removed fromthe bone of the patient and the resulted variable diameter bore,comprised of initial bore 300 and undercut bore 302, can be seen asillustrated in FIG. 20.

Reference is now made to FIG. 21, which is a simplified flow chartillustrating an example of the use of the bone material removal device100 with the cannula assembly 120 shown in FIG. 1 and to FIG. 22, whichis a simplified block diagram illustrating an example of the method ofusing the bone material removal device 100 and cannula assembly 120 ofFIG. 1.

The mechanism of the device and method of its operation as described indetail above is further illustrated particularly in FIGS. 20 and 21.

Reference is now made to FIGS. 23A-23C, which are three simplified planview illustrations of a cutting tooth element, forming part of the bonematerial removal device 100 of FIG. 2, constructed and operative inaccordance with some embodiments of the present invention.

In accordance with some embodiments of the present invention, analternative and optional cutting tooth 440 is provided as part of thebone material removal device 100, instead of cutting tooth 140 as seenin FIG. 10.

In the exemplary embodiment shown in FIGS. 23A-23C, cutting toothelement 440 comprises an integrally made element having a centralportion 442 having a sharp edge 444 formed thereon. Preferably, in someembodiments, one, two or more recesses 446 are formed within the centralportion 442 for insertion of pins 448 therethrough to enable attachmentof the cutting tooth 440 to tip element 108 while providing for axialdisplacement of the central portion 442 of the cutting tooth 440 alongan axis 447 that is disposed transversely to longitudinal axis 109. Insome embodiments, in operation, pins 448 act as selective stoppers,stopping tooth element 440 from displacing axially but allowing movementin other directions, e.g., allowing tooth element 440 to slide radiallywhen urged axially distally and extend radially in respect to shaft 530.A leaf spring portion 450 is generally attached or integrally formed atthe opposite proximal and distal sides of the central portion 442.

Reference is now made to FIG. 24, which is a simplified assembled planview illustration of the bone material removal device 100 of FIG. 2,constructed and operative in accordance with some embodiments of thepresent invention, shown in a closed operative orientation and a partialsection view and an enlargement thereof.

As noted above, the longitudinal shaft 130 having a threaded portion 132is configured to be partially inserted into the tubular element 104 andpartially into rotating element 102, such that the threaded portion 132of shaft 130 is engaged with the internal threading of the rotatingelement 102.

In the embodiments depicted in FIGS. 24 and 25 a shaft element 530 isprovided as an optional alternative to shaft element 130. In someembodiments, shaft element 530 is preferably a longitudinal integrallymade element having a proximal end with threaded portion 132 and adistal end 540 configured for partial insertion into the tip element108. A through bore 202 extending transversely with respect tolongitudinal axis 109 is located adjacent and slightly distally fromthreaded portion 132. Through bore 202 is configured for insertion ofpositioning pin 134 there through.

It is further seen in FIGS. 24 and 25 that the distal end 540 of shaftelement 530 comprises a distally tapered portion 542 defining a taperedsurface 544. The tapered surface 544 of shaft element 530 is configuredfor engagement with the central portion 442 of the cutting tooth 440.

In some embodiments, at least a portion of central portion 442 of thecutting tooth 440 is disposed in the path of, and interferes with, axialdistal displacement of shaft element 530. Axial distal displacement ofshaft element 530 brings distally tapered portion 542 to slide undercentral portion 442. Pins 448 act as a selective stoppers, stoppingtooth element 440 from displacing axially but allowing displacement ofcentral portion 442 in a radial direction and when urged distallyaxially by distally tapered portion 542 to extend radially in respect toshaft 530 as shown in FIG. 25.

It is further seen that the shaft 530 is configured to be connected tothe tubular element 104 by an indicating pin 134, which is slidablydisposed within guiding slot 180 of the tubular element 104.

Preferably and in some embodiments, a longitudinal guiding slot 212formed on tip element 108 adjacent drilling edge 240. Guiding slot 212extend along an axis, which is transversely disposed with respect tolongitudinal axis 109. Guiding slot 212 is configured for partialinsertion of cutting tooth 440 there through. It is appreciated that anynumber of guiding slots 212 can be formed in the tip element 108 foraccommodating a number of cutting teeth 440.

It is seen in the embodiment depicted in FIG. 24 that the bone materialremoval device 100 is positioned in a closed operative orientation, inwhich the cutting tooth 440 is in a closed orientation, fully receivedby hollow 416 and does not protrude through guiding slot 212, thus thediameter of the bore formed in the bone of the patient while drilling inthe closed operative orientation of the bone material removal device 100is equal to the outer diameter of tip element 108.

It is further particularly seen in FIG. 24 that the shaft element 530 isslidably engaged with cutting tooth 440, such that the distally taperedsurface 544 of the shaft element 530 engages the central portion 442 ofthe cutting tooth and the distal edge 560 of the shaft element 530 isgenerally aligned with or slightly distally extends with respect to thedistal edge of the central portion 442 of the cutting tooth 440, thisposition is defined as the proximal operative orientation of the shaftelement 530.

It is a particular feature of some embodiments of the present inventionthat when the shaft element 530 is positioned in its proximal operativeorientation, the cutting tooth 440 is fully received by and enclosedwithin the tubular element 104 hollow 416 and does not protrude throughguiding slot 212 due to the fact that the leaf springs 450 arepositioned in their unstressed orientation, biasing the cutting tooth440 to its closed position inside hollow 416, since there is no forceexerted on the central portion 442 of the cutting tooth 440 at theproximal operative orientation of the shaft element 530.

FIG. 25 is a simplified assembled plan view illustration of the bonematerial removal device 100 of FIG. 2, constructed and operative inaccordance with some embodiments of the present invention, shown in anopen operative orientation and a partial section view and an enlargementthereof.

It is seen in FIG. 25 that the bone material removal device 100 ispositioned in an open operative orientation, in which the cutting tooth440 is open and protrudes through guiding slot 212, thus the diameter ofthe bore formed in the bone of the patient while drilling in the openoperative orientation of the bone material removal device 100 is greaterthan the outer diameter of tip element 108.

It is a particular feature of some embodiments of the present inventionthat threaded portion 132 of shaft element 530 is threadably attached toinner threading 170 of rotating element 102. The shaft element 530 isdisposed at its distal operative orientation in this open position andis attached to the tubular element 104 by means of indicating pin 134.

It is a particular feature of some embodiments of the present inventionthat the indicating pin 134 is positioned at the distal end of guidingslot 180 of tubular element 104 when the bone material removal device ispositioned at the open operative orientation, since the indicating pin134 is inserted into bore 202 of shaft element 530, which is disposed atthe distal operative orientation at this stage.

It is further particularly seen in FIG. 25 that the shaft element 530 isslidably engaged with cutting tooth 440, such that the distally taperedsurface 544 of the shaft element 530 engages the central portion 442 ofthe cutting tooth and the distal edge 560 of the shaft element 530protrudes distally with respect to the distal edge of the centralportion 442 of the cutting tooth 440, this position is defined as thedistal operative orientation of the shaft element 530.

It is a particular feature of some embodiments of the present inventionthat when the shaft element 530 is positioned in its distal operativeorientation, the cutting tooth 440 is forced radially outwardly throughthe guiding slot 212 of tip element 108 against the bias of leaf springs450 that are now positioned in their stressed orientation. Force isexerted on the central portion 442 of the cutting tooth 440 at thedistal operative orientation of the shaft element 530, since a widerportion of the shaft element 530 engages the central portion 442 of thecutting tooth and the leaf springs 450 are radially deflected outwardlyin a stressed orientation, causing radial outward deflection of thecentral portion 442 of the cutting tooth 440, with the cutting edge 444formed thereon. Once shaft element 530 is displaced proximally, radiallydeflected stressed leaf springs 450 tend to return to their restingunstressed state urging central portion 442 of the cutting tooth 440radially inwardly into hollow 416 as shown in FIG. 24.

It is a particular feature of some embodiments of the present inventionthat when the shaft element 530 is positioned in its distal operativeorientation, the cutting tooth 440 is axially displaced along an axisthat extends transversely radially to longitudinal axis 109 to protrudethrough guiding slot 212 of tip element 108.

It is a further particular feature of some embodiments of the presentinvention that longitudinal displacement of shaft element 530 urges themovement of the central portion 442 of cutting tooth 440 from itsinitial orientation against leaf springs 450 and causes the cuttingtooth 440 to protrude through guiding slot 212 of tip element 108.

It is appreciated that shaft element 530 and its engagement with otherparts of the bone material removal device 100 is generally similar toshaft element 130 in all respects other than the features described indetail hereinabove.

Reference is now made to FIG. 26A, which is a simplified assembled viewillustration of an embodiment of a bone material removal device and acannula assembly, constructed and operative in accordance with someembodiments of the present invention and to FIG. 26B, which is asimplified exploded view illustration of the bone material removaldevice of FIG. 26A.

It is seen in the embodiments shown in FIGS. 26A and 26B that a bonematerial removal device 600 includes a rotating element 602 configuredto be rotatably attached to a tubular element 604 by a sleeve 606 and acannula retaining element 607. A tip element 608 is attached orintegrally made with the tubular element 604.

It is seen that rotating element 602, tubular element 604, sleeve 606,cannula retaining element 607 and tip element 608 are all arranged alonga single mutual longitudinal axis 609.

It is additionally seen in FIG. 26B that a cannula assembly 620 isconfigured to be mounted over the tubular element 604 and arranged alonglongitudinal axis 609. Cannula assembly includes a cannula handle 622and a cannula tube 624.

It is appreciated that the tubular element 604 is preferably made of abiocompatible material, e.g., metal.

It is additionally seen in FIG. 26B that a plurality of O-rings 625, oralternatively and optionally any other friction enhancing elements, areprovided on cannula retaining element 607.

It is further seen in FIG. 26B that the rotating element 602 isconfigured to be rotatably attached to the sleeve element 606. Sleeveelement 606 comprises a portion with an outer threading 626 which isconfigured to engage an inner threading of cannula retaining element607. Cannula retaining element 607 in turn is configured to be fixedlyconnected to tubular element 604. The sleeve 606 enables free rotationalmovement of the rotating element 602 relative to the tubular element604.

A longitudinal shaft 630 having a proximal portion 632 configured to bepartially inserted into the tubular element 604 and partially intorotating element 602.

It is further seen that the shaft 630 is configured to be connected tothe sleeve 606 by an indicating pin 634.

It is seen in FIG. 26B that tip element 608 is either attached orintegrally made with tubular element 604. A Cutting tooth 640 isconfigured to be attached to the distal end of the tubular element 604.

Reference is now made to FIG. 27, which is a simplified pictorialillustration of rotating element 602, forming part of the bone materialremoval device 600 of FIG. 26B.

Rotating element 602 is a generally longitudinal hollow cylindricalintegrally made element having a proximal end 660 configured to beoptionally inserted into a power tool (not shown) and a distal end 662configured to be optionally inserted into the sleeve 606.

Reference is now made to FIGS. 28 and 29, which are pictorialillustrations of two parts of shaft element 630, forming part of thebone material removal device 600 of FIG. 26B.

It is seen in FIGS. 28 and 29, which together form the shaft element 630that it is preferably longitudinal integrally made element havingproximal portion 632 and a distal end 700 for insertion into the tubularelement 604. The distal end 700 of shaft element 600 comprises adistally extending tapered surface 702. A through bore 704 extendingtransversely with respect to longitudinal axis 609 is located adjacentand slightly distally from the proximal end of proximal portion 632.Through bore 704 is configured for insertion of positioning pin 634there through.

Reference is now made to FIG. 30, which is a simplified pictorialillustration of sleeve 606, forming part of the bone material removaldevice of FIG. 26B.

It is appreciated that sleeve 606 forms the distal portion of tubularelement 604. Sleeve 606 comprises a generally longitudinal hollowcylindrical integrally made element having a proximal end 710 configuredto be attached to rotating element 602 and a distal end 712 configuredto be attached to cannula retaining element 607.

It is further seen in FIG. 30 that preferably two longitudinal guidingslots 720 are formed on sleeve 606. Guiding slots 720 extend along anaxis, which is transversely disposed with respect to longitudinal axis609 and are preferably aligned with each other.

Reference is now made to FIG. 31, which is a simplified pictorialillustration of a proximal portion of a tubular element 604, forms partof the bone material removal device 600 of FIG. 26B and to FIG. 32,which is a pictorial illustration of a distal portion of the tubularelement 604, forming part of the bone material removal device 600 ofFIG. 26B.

It is appreciated that the distal and the proximal portions of thetubular element 604 can be either attached to each other or integrallymade with each other.

The distal portion of the tubular element 604 comprises a distal end730, which is configured to be connected to the tip element 608. In someembodiments, tubular element 604 comprises an opening 732 adjacent thedistal end 730 for receiving the cutting tooth 640 therein and allow thecutting tooth 640 to protrude through the opening 732 when the cuttingtooth 640 is situated in an open operative orientation.

The proximal portion of the tubular element 604 comprises a proximal end734 that is configured to be attached to cannula retaining element 607.

Tubular element 604 comprises a bore 740 throughout at least a portionof its length, which is configured to receive and enclose shaft element630.

Reference is now made to FIG. 33, which is a simplified pictorialillustration of cutting tooth 640, forms part of the bone materialremoval device 600 of FIG. 26B.

Cutting tooth 640 comprises an integrally made element having a centralportion 742 having a sharp edge 744 formed thereon. Preferably one, twoor more recesses 746 are formed within the central portion 742 forinsertion of pins 448 therethrough to enable attachment of the cuttingtooth 740 to tubular element 604 while providing for axial displacementof the central portion 742 of the cutting tooth 640 along an axis 747that is disposed transversely to longitudinal axis 609. In someembodiments, in operation, pins 448 act as selective stoppers, stoppingcutting tooth 640 from displacing axially but allowing movement in otherdirections, e.g., allowing tooth element 440 to slide radially whenurged axially distally and extend radially in respect to longitudinalaxis 609.A leaf spring portion 750 is generally attached or integrallyformed at the opposite distal and proximal sides of the central portion742.

Reference is now made to FIG. 34, which is a pictorial illustration ofcannula retaining element 607, forms part of the bone material removaldevice 600 of FIG. 26B.

Cannula retaining element 607 is preferably and in some embodiments anintegrally made generally elongate cylindrical element having a proximalportion 760 having a threaded inner portion 762 which is configured toengage an outer threaded portion of sleeve 606. The cannula retainingelement 607 also comprises a distal portion 764.

Typically and in some embodiments one, two or more circumferentialgrooves 766 are located adjacent the distal portion 764 for positioningof O-rings 625 therein.

Reference is now made to FIG. 35, which is a simplified exploded viewillustration of the cannula assembly 620, constructed and operative inaccordance with some embodiments of the present invention.

It is seen in FIG. 35 that the cannula assembly 620 includes a handle622 and a hollow cannula 624, which is configured to be connected to thehandle 622 and mounted over the bone material removal device 600 andarranged along longitudinal axis 609.

Reference is now made to FIG. 36, which is a simplified assembled planview illustration of an exemplary embodiment of the bone materialremoval device 600 of FIG. 26B shown in a closed operative orientationand enlargements thereof and to FIG. 37, which is a simplified sectionalview illustration of the bone material removal device 600 of FIG. 36shown in the closed operative orientation and enlargements thereof,section view being taken along lines A-A in FIG. 36.

Reference is additionally made to FIGS. 40A and 40B, which aresimplified sectional illustrations of an exemplary embodiment of thebone material removal device 600 and the cannula assembly 620 of FIG.26A shown in the closed operative orientation partially inserted into abone of a patient and an enlargement thereof.

It is seen in FIGS. 36 and 37 and in FIGS. 40A and 40B that the bonematerial removal device 600 is positioned in a closed operativeorientation, in which the cutting tooth 640 is closed and receivedinside hollow 416, and does not protrude through opening 732, thus thediameter of the bore formed in the bone of the patient while drilling inthe closed operative orientation of the bone material removal device 600is equal to the outer diameter of the distal portion of tubular element604 shown in FIG. 32.

It is seen that tubular element 604 is rotatably connected to rotatingelement 602 by means of sleeve 606.

It is a particular feature of some embodiments of the present inventionthat threaded portion 626 of sleeve 606 is interthreaded with innerthreading 762 of cannula retaining element 607. The shaft element 630 isdisposed at its proximal operative orientation in this closed positionand is attached to the tubular element 604 by means of indicating pin634.

It is a particular feature of some embodiments of the present inventionthat the indicating pin 634 is positioned at the proximal end of guidingslot 720 of sleeve 606 when the bone material removal device ispositioned at the closed operative orientation, since the indicating pin634 is inserted into bore 704 of shaft element 630, which is disposed atthe proximal operative orientation at this stage.

It is further particularly seen in FIGS. 37, 40A and 40B that theproximally tapered surface 702 of shaft element 630 engages the centralportion 742 of cutting tooth 640 but does not urge it to be radiallydisplaced, thus the cutting tooth 640 remains closed in this operativeorientation inside hollow 416.

It is a particular feature of some embodiments of the present inventionthat when the shaft element is positioned in its proximal operativeorientation, the cutting tooth 640 is fully enclosed within the tubularelement 604 hollow 416 and does not protrude through opening 732.

It is particularly seen in the embodiments shown in FIGS. 40A and 40Bthat bone material removal device 600 is inserted into the bore ofcannula assembly 620. It is appreciated that the cannula assembly ispositioned at its distal position in respect to tubular element 604,thus the cannula handle does not engage the cannula retaining element607 and the tubular element 604 freely rotates with respect to cannulaassembly 620 to drill or ream a bore in a bone.

It is seen in FIG. 40B that an initial bore 800 of a first diameter isformed in the bone of the patient while drilling with the bone materialremoval device 600 positioned in its closed operative orientation. It isnoted that this initial drilling is provided while the rotating element602 is rotated in a first rotational direction, in this exemplaryembodiment, in a clockwise direction.

While the rotating element 602 and the tubular element 604 are rotatingin a clockwise rotational direction, the sharp drilling tip of tip 608engages the bone of the patient and creates initial bore 800 therein.

It is appreciated that any number of openings 732 can be formed intubular element 604 for accommodating one or more cutting teeth 640.

It is appreciated that the shaft element 630 is slidably engaged withcutting tooth 640, such that the distally tapered surface 702 of theshaft element 630 engages the central portion 742 of the cutting toothand the distal edge of the shaft element 630 is generally aligned withor slightly distally extends with respect to the distal edge of thecentral portion 642 of the cutting tooth 640, this position is definedas the proximal operative orientation of the shaft element 630.

It is a particular feature of some embodiments of the present inventionthat when the shaft element 630 is positioned in its proximal operativeorientation, the cutting tooth 640 is fully enclosed within the tubularelement 604 hollow 416 and does not protrude through opening 732 due tothe fact that the leaf springs 750 are positioned in their unstressedorientation, biasing the cutting tooth 640 into its closed position,since there is no force exerted on the central portion 742 of thecutting tooth 640 at the proximal operative orientation of the shaftelement 630.

Reference is now made to FIG. 38, which is a simplified assembled planview illustration of an exemplary embodiment of the bone materialremoval device 600 of FIG. 26B shown in an open operative orientationand enlargements thereof and to FIG. 39, which is a simplified sectionalview illustration of the bone material removal device 600 of FIG. 38shown in the open operative orientation and enlargements thereof,section view being taken along lines B-B in FIG. 38. Reference is nowmade to FIG. 41, which is a simplified sectional view illustration of anexemplary embodiment of the bone material removal device 600 of FIG. 26Ashown in an open operative orientation and enlargements thereof.

Reference is further made to FIG. 42, which is a simplified sectionalview illustration of an exemplary embodiment of the bone materialremoval device 600 of FIG. 26A shown during removal from the bone of thepatient.

It is seen in FIGS. 38, 39 and 41 that the bone material removal device600 is positioned in an open operative orientation, in which the cuttingtooth 640 is open, extends radially and protrudes through opening 732,thus the diameter of the bore formed in the bone of the patient whiledrilling in the open operative orientation of the bone material removaldevice 600 is greater than the outer diameter of tubular element 604.

It is a particular feature of some embodiments of the present inventionthat threaded portion 626 of sleeve 606 is interthreaded with threading762 along a portion of an inner wall of cannula retaining element 607.The shaft element 630 is disposed at its distal operative orientation inthis open position and is attached to the tubular element 604 by meansof indicating pin 634.

It is a particular feature of some embodiments of the present inventionthat the indicating pin 634 is positioned at the distal end of guidingslot 720 of tubular element 604 when the bone material removal device ispositioned at the open operative orientation, since the indicating pin634 is inserted into bore 704 of shaft element 630, which is disposed atthe distal operative orientation at this stage.

It is further particularly seen in FIGS. 37, 40A and 40B that theproximally tapered surface 702 of shaft element 630 engages the centralportion 742 of cutting tooth 640 and urges it to be axially displaced,thus the cutting tooth 640 moves to its open operative orientation.

It is a particular feature of some embodiments of the present inventionthat when the shaft element 630 is positioned in its distal operativeorientation, the cutting tooth 640 protrudes from tubular element 604through opening 732.

It is particularly seen in FIG. 41 that bone material removal device 600is inserted into the bore of cannula assembly 620. It is appreciatedthat the cannula assembly is positioned at its proximal position, thusthe cannula handle engages the cannula retaining element 607 andfriction force is created between the tubular element 604 and thecannula assembly 620 in order to stop the rotational movement of thetubular element 104 to enable changing the drilling rotationaldirection. Frictional force is created by engagement of cannula assembly620 with O-rings 625 that are located on the cannula retaining element607.

It is particularly seen in FIG. 41 that bone material removal device 600is inserted into the bore of cannula assembly. It is seen in FIG. 41that an undercut bore 802 is formed over the initial bore 800, undercutbore 802 having a second diameter, which is greater than the firstdiameter while drilling with the bone material removal device 600positioned in its open operative orientation in which central portion742 extends radially beyond opening 732. It is noted that this undercutbore drilling is provided while the rotating element 602 is rotated in asecond rotational direction, in this exemplary embodiment, in acounter-clockwise direction.

It is a particular feature of some embodiments of the present inventionthat once the cannula assembly is located at its proximal position, therotation of the tubular element 604 is momentarily stopped, therotational direction of the drilling can be reversed, thus causing thethreaded portion 626 of shaft element 630 to unthread from internalthreading 762 of cannula retaining element 607. Since indicating pin 634attaches the shaft element 630 to the guiding slot 720 of the sleeve606, rotation of the shaft element 630 is prevented and this unthreadingcauses axial displacement of the shaft element 630 in a distaldirection.

The extent of longitudinal displacement of the shaft element 630 dependson the length of guiding slot 720, thus during the axial displacement ofshaft element 630 in a distal direction in respect to cannula retainingelement 607, the indicating pin 634 is displaced along the guiding slot720 from its proximal end to its distal end.

It is a further particular feature of some embodiments of the presentinvention that longitudinal displacement of shaft element 630 urges thecutting tooth 640 to be displaced radially along axis 747 and protrudethrough opening 732 of tubular element 604.

In some embodiments, while the rotating element 602 and the tubularelement 604 are rotating in a counter-clockwise rotational direction,the cutting edge 744 of cutting tooth 740 engages the bone of thepatient and creates undercut bore 802 therein. It is noted that thedrilling rotational direction can be reversed at any time by displacingthe cannula assembly 620 to its proximal position and the bone materialremoval device 600 can be advanced and retracted to and from the bone ofthe patient in order to create the desired length of undercut bore 802.

It is appreciated that in some embodiments, in order to return to theclosed operative orientation of the bone material removal device 600,cannula assembly has to be displaced proximally to engage the cannularetaining element 607 so that the drilling rotational directional isreversed in order to urge the shaft element 630 to be displaced axiallyto the proximal position, thus releasing the cutting tooth 640 to bebiased to the closed position.

At this stage, the bone material removal device 600 can be removed fromthe bone of the patient and the resulted variable diameter bore,comprised of initial bore 800 and undercut bore 802, can be seen asillustrated in FIG. 42.

It is further particularly seen in FIG. 41 that the shaft element 630 isslidably engaged with cutting tooth 640, such that the distally taperedsurface 702 of the shaft element 630 engages the central portion 742 ofthe cutting tooth and the distal edge of the shaft element 630 protrudesdistally with respect to the distal edge of the central portion 742 ofthe cutting tooth 640, this position is defined as the distal operativeorientation of the shaft element 630.

It is a particular feature of some embodiments of the present inventionthat when the shaft element 630 is positioned in its distal operativeorientation, the cutting tooth 640 is forced radially outwardly throughand beyond the opening 732 of tubular element 604 against bias the leafsprings 750 now positioned in their stressed orientation. Cutting tooth640 is forced radially outwardly into its open position, extendingradially through and beyond opening 732, since there is force exerted onthe central portion 742 of the cutting tooth 640 at the distal operativeorientation of the shaft element 630, resulting from the geometry of awider portion of the shaft element 630 that engages the central portion742 of the cutting tooth the leaf springs 750 are radially deflectedoutwardly, thus causing radial outward deflection of the central portion742 of the cutting tooth 640, with the cutting edge 744 formed thereon.

It is a particular feature of some embodiments of the present inventionthat when the shaft element 630 is positioned in its distal operativeorientation, the cutting tooth 640 is axially displaced along an axis747 that extends radially transversely to longitudinal axis 609 toprotrude through opening 732 of tubular element 604.

It is noted that the bone material removal device 100 according to someembodiments of the present invention can be useful in various surgicalprocedures, such as for example, insertion of an anchor, administrationof a drug, insertion of a graft and insertion of an implant in AVNtreatment procedures.

Reference is now made to FIG. 43, which is a simplified exploded viewillustration of a bone material removal device and a cannula assembly,constructed and operative in accordance with some embodiments of thepresent invention. Reference is additionally made to FIG. 44, which is asimplified exploded view illustration of the bone material removaldevice of FIG. 43, constructed and operative in accordance with someembodiments of the present invention.

It is seen in FIGS. 43 and 44 that a bone material removal device 900includes a rotating element 902 configured to be rotatably attached to aguiding element 904 by means of pins 905. Guiding element 904 is in turnslidably attached to a body crank element 906 by means of guiding pin908 and bearing crank 910.

It is seen that a stopper 912 is arranged to be mounted onto body crankelement 906 for limiting axial displacement of guiding pin 908.

It is further seen in FIGS. 43 and 44 that a shaft element 920 isfixedly attached to guiding element 904 and a tubular element 922 isfixedly attached to body crank element 906 and surrounds shaft element920. It is noted that a tennon 930 is configured to be insertable into agroove 932 formed in the tubular element 922 for cooperation with acannula assembly 940.

A tip element 950 is attached or integrally made with the tubularelement 922. A tooth 952 is arranged to be connected to the shaftelement 920 by means of a hinge 954 and pivotably connected to the tipelement 950. It is seen in the embodiment in FIG. 44 that hinge element954 is configured to be rotatably attached at a first end by a pin 938to an end of the shaft element 920 and at a second end to a cuttingtooth 952 via pin 942. The cutting tooth 952 is configured to berotatably attached to a tip element 950 via a pin 944.

It is seen that rotating element 902, guiding element 904, body crankelement 906, bearing crank 910, stopper 912, shaft element 920, tubularelement 922 and tip element 950 are all arranged along a single mutuallongitudinal axis 960.

It is seen in the embodiment shown in FIG. 43 that cannula assembly 940is configured to be mounted over the tubular element 922 and arrangedalong longitudinal axis 960.

It is appreciated that the tubular element 922 is preferably made of abiocompatible material, e.g. metal.

It is further seen in FIGS. 43 and 44 an is described in greater detailelsewhere herein, that the guiding element 904 includes typically atleast one helical path 970 cut through a wall of guiding element 904that typically slidingly receives at least one pin 905 coupled torotating element 902 and at least one aperture 972 accommodating aguiding pin 908. It is a particular feature of some embodiments of thepresent invention that rotational displacement of pins 905 along andwithin helical path 970 of guiding element 904 is converted into axiallinear displacement of guiding element 904 bringing about axial lineardisplacement of guiding pin 908 within a slot 974 formed in body crankelement 906, axial linear displacement of guiding element 904 urgesshaft element 920 to axial displace along longitudinal axis 960. Thislongitudinal displacement of shaft element 920, urges pivoting of hinge954, and thereby causes pivoting of tooth 952 relative to tip element950.

Reference is now made to FIG. 45, which is a simplified exploded viewillustration of an exemplary embodiment of the cannula assembly 940 ofFIG. 43, constructed and operative in accordance with some embodimentsof the present invention.

It is seen in FIG. 45 that the cannula assembly 940 includes hollowcannula body 980 and a cannula inner sleeve 990, which is configured tobe mounted over the bone material removal device 900 and arranged alonglongitudinal axis 960. Cannula assembly 940 further includes a cannulacover 992, which is con figured to be fixedly attached to the cannulabody 980 and a plurality of cannula breaks 994, which engage the cannulainner sleeve 990.

The cannula cover 992 is configured to be fixedly attached to cannulabody 980 by means of fixating pins 995. The cannula breaks 994 arefixedly mounted between cannula body 980 and cannula inner sleeve 990 bymeans of fixating pins 996.

Reference is now made to FIG. 46, which is a simplified pictorialillustration of a tubular element 922, forms part of the bone materialremoval device 900 of FIG. 44.

Tubular element 922 is a generally longitudinal hollow cylindricalintegrally made element having a proximal end 1000 configured to beattached to body crank element 906 and a distal end 1002 configured tobe attached to tip element 950 or integrally made therewith. Tubularelement 922 comprises a bore 1004 that extends throughout tubularelement 922, which is configured to receive and enclose shaft element920.

It is further seen in FIG. 46 that groove 932 is formed on tubularelement 922 and is configured to receive tennon 930 thereinto.

Reference is now made to FIG. 47, which is a simplified pictorialillustration of an exemplary embodiment of the shaft element 920,forming part of the bone material removal device 900 of FIG. 44.

It is seen in FIG. 47 that shaft element 920 is preferably longitudinalintegrally made element having a proximal end 1010, configured to beattached to guiding element 904 and a distal end 1012 for partialinsertion into the tip element 950.

It is further seen in FIG. 47 that a recess 1014 is formed at the distalend 1012 of shaft element 920 and extends slightly longitudinallytherefrom. A bore 1016 is formed at the distal end 1012 of shaft element920 and extends transversely with respect to recess 1014. The recess1014 and bore 1016 are configured for attachment of the hinge 954 toshaft element 920.

Reference is now made to FIG. 48, which is a simplified pictorialillustration of the body crank element 906, forms part of the bonematerial removal device 900 of FIG. 44.

It is seen in the embodiment shown in FIG. 48 that body crank element906 is preferably longitudinal integrally made element having a proximalend 1020, configured to be attached to bearing crank 910 and a distalend 1022 configured to be attached to the tubular element 922.

The body crank element 906 defines a hollow bore 1024 therewithin forpartial insertion of guiding element 904 thereinto. As mentioned above,slot 974 is formed in the body crank element 906 for guiding of guidingpin 908 therealong and an indication window 1026 is formed through bodycrank element 906 and is spaced proximally from slot 974.

Reference is now made to FIG. 49, which is a simplified pictorialillustration of the guiding element 904, forms part of the bone materialremoval device 900 of FIG. 44.

It is seen in FIG. 49 that guiding element 904 is preferablylongitudinal integrally made element having a proximal end 1030,configured to be attached to the rotating element 902 and a distal end1032 configured to be attached to the shaft element 920.

A recess 1034 is formed at the distal end 1032 of guiding element 904.Typically, one, two or more indication elements 1040 are formed in agenerally intermediate location of guiding element 904, which may becoated with different colors, in order to indicate whether the cuttingtooth 952 is disposed in its closed or open operative orientation, usingthe longitudinal displacement of the guiding element 904 as indicationof the operative orientation of tooth 952.

Reference is now made to FIG. 50, which is a simplified pictorialillustration of an exemplary embodiment of the rotating element 902,forms part of the bone material removal device 900 of FIG. 44.

A recess 1050 is formed in the distal end of rotating element 902 forinsertion of the proximal end 1010 of shaft element 920 thereinto.

A bore 1052 is formed proximally of distal end of the rotating element902 for insertion of pins 905 therethrough.

Reference is now made to FIG. 51, which is a simplified pictorialillustration of pin element 905, forming part of the bone materialremoval device 900 of FIG. 44.

Pin element 905 is an integrally formed element arranged along an axis1060, which is generally perpendicular to longitudinal axis 960.

It is noted that pin element 905 includes a longitudinal portion 1062for engagement with helical paths 970 in guiding element 904 and anoutwardly extending circumferential flange 1064 for attaching the pinelements 905 to rotating element 902.

It is noted that the tip element 950, tooth 952 and hinge 954inaccordance to this embodiment of the present invention are substantiallysimilar to the tip element, tooth and hinge element described and shownin FIGS. 8-10 of the present application.

Reference is now made to FIG. 52, which is a simplified assembled planview illustration of an exemplary embodiment of the bone materialremoval device 900 of FIG. 44 shown in a closed operative orientationand enlargements thereof. Reference is additionally made to FIGS. 53Aand 53B, which are respective plan view and section view illustration ofan exemplary embodiment of the bone material removal device 900 of FIG.44 shown in the closed operative orientation.

It is seen in FIGS. 52, 53A and 53B where an exemplary embodiment of thebone material removal device 900 is shown in an assembled and closedoperative orientation that guiding element 904 is received into recess1050 of rotating element 902, such that pins 905 are received withinhelical paths 970 of guiding element 904 and provide for longitudinaldisplacement of the guiding element 904 relative to the rotating element902 along longitudinal axis 960. As shown in FIG. 53B, a shaftdisplacement actuator comprises a first portion mainly guide element 904that is rigidly coupled to shaft element 920 and a second portion mainlyrotating element 902, rotatingly coupled to guide element 904.

Guiding element 904 is inserted into bore 1024 of body crank element 906through the proximal end thereof, and guiding pin 908 connects theguiding element 904 and body crank element 906, such that guiding pin908 is slidably moveable along slot 974 of body crank element 906. It isalso seen that the proximal end 1010 of shaft element 920 is fixedwithin recess 1034 of guiding element 904.

Stopper 912 is mounted onto and partially encircles body crank element906, such as to limit the slidable longitudinal displacement of pin 908along slot 974 of body crank element 906. Proximal end 1000 of tubularelement 922 is fixed within the bore 1024 of body crank element 906.

It is further seen particularly in FIG. 53B that hinge element 954 ishingedly attached by a pin within recess 1014 of shaft element 920, andthe hinge element 954 is additionally hingedly attached to the cuttingtooth 952, which is in this closed operative orientation of the bonematerial removal device 900 is fully enclosed within tip element 950,since the shaft element 920 is positioned in its proximal position.

It is seen in FIGS. 52-53B that the bone material removal device 900 ispositioned in the closed operative orientation, in which the cuttingtooth 952 is closed, thus the diameter of the bore formed in the bone ofthe patient while drilling in the closed operative orientation of thebone material removal device 900 is equal to the outer diameter of tipelement 950.

It is a particular feature of some embodiments of the present inventionthat pins 905 are engaged with helical paths 970 of guiding element 904and the guiding element 904 is disposed in its proximal position, inwhich the cutting tooth 952 is closed.

It is a further particular feature of some embodiments of the presentinvention that a first indication element 1040 formed on guiding element904 is seen through indication window 1026 formed in body crank element906, thus indicating to the user that the cutting tooth 952 is disposedin its closed operative orientation.

It is a particular feature of some embodiments of the present inventionthat the guiding pin 908 is positioned in the proximal end of slot 974of body crank element 906 when the bone material removal device 900 ispositioned at the closed operative orientation, since the guiding pin908 is inserted into bore 972 of guiding element 904, which is disposedat the proximal operative orientation at this stage.

Reference is now made to FIG. 54, which is a simplified assembled planview illustration of an exemplary embodiment of the bone materialremoval device 900 of FIG. 44 shown in an open operative orientation andenlargements thereof. Reference is additionally made to FIGS. 55A and55B, which are respective plan view and section view illustration of anexemplary embodiment of the bone material removal device 900 of FIG. 44shown in the open operative orientation.

It is seen in FIGS. 54-55B that the bone material removal device 900 isshown in an assembled and open operative orientation. It is seenparticularly in FIG. 55B that hinge element 954 is hingedly attached bya pin within recess 1014 of shaft element 920, and the hinge element 954is additionally hingedly attached to the cutting tooth 952, which is inthis open operative orientation of the bone material removal device 900extends radially outwardly from tip element 950, since the shaft element920 is positioned in its distal position in this open operativeorientation.

It is seen in FIGS. 54-55B that the bone material removal device 900 ispositioned in the open operative orientation, in which the cutting tooth952 is open, thus the diameter of the bore formed in the bone of thepatient while drilling in the open operative orientation of the bonematerial removal device 900 is larger than the outer diameter of tipelement 950.

It is a particular feature of some embodiments of the present inventionthat pins 905 are displaced along helical paths 970 of guiding element904, thus positioning the guiding element 904 in its distal position,the displacement of the guiding element 904 urges distal longitudinaldisplacement of shaft element 920, thus providing for pivoting of thehinge element 954 and in turn pivoting of tooth 952 and positioningthereof in the open operative orientation.

It is a further particular feature of some embodiments of the presentinvention that a second indication element 1040 formed on guidingelement 904 is seen through indication window 1026 formed in body crankelement 906, thus indicating to the user that the cutting tooth 952 isdisposed in its open operative orientation.

It is a particular feature of some embodiments of the present inventionthat the guiding pin 908 is positioned in the distal end of slot 974 ofbody crank element 906 when the bone material removal device 900 ispositioned at the open operative orientation, since the guiding pin 908is inserted into bore 972 of guiding element 904, which is disposed atthe distal operative orientation at this stage.

Reference is now made to FIGS. 56A and 56B, which are respectivesimplified pictorial and sectional illustrations of an exemplaryembodiment of the cannula body 980, forms part of the cannula assembly940 of FIG. 45.

It is seen in FIGS. 56A and 56B that the cannula body 980 is an elongateintegrally formed element, that is arranged along longitudinal axis 960.The cannula body 980 comprises a proximal end 1100, a distal end 1102and abore 1104.

In some embodiments the bore 1104 extends throughout the full lengthcannula body 980 and comprises a distal generally cylindrical portion1106 having a first diameter, an intermediate cylindrical portion 1108having a second diameter, which is greater than the first diameter and aproximal cylindrical portion 1110 having a third diameter, generallygreater than the second diameter.

It is further seen that a plurality of bores 1112 are formed in theproximal cylindrical portion 1110 for insertion of fixation pinstherethrough. Bores 1112 extend along axes that are generallyperpendicular to longitudinal axis 960. Additional bores 1114 are formedin proximal cylindrical portion 1110 and extend along axes parallel tolongitudinal axis 960 for insertion of different fixation pinstherethrough.

Reference is now made to FIGS. 57A and 57B, which are respectivesimplified pictorial and sectional illustrations of the cannula innersleeve 990, forming part of the cannula assembly 940 of FIG. 45.

It is seen in FIGS. 57A and 57B that the cannula inner sleeve 990 is anelongate integrally formed element, that is arranged along longitudinalaxis 960.

The cannula inner sleeve 990 defines an outer cylindrical surface 1120and a bore 1122, which extends throughout the full length of cannulasleeve 990 and defines an inner cylindrical surface 1124. A longitudinalgroove 1126 is formed on the inner cylindrical surface 1124.

Reference is now made to FIG. 58, which is a simplified pictorialillustration of the cannula cover 992, forms part of the cannulaassembly 940 of FIG. 45.

It is seen in FIG. 58 that cannula cover 992 is an integrally formedelement, that is arranged along longitudinal axis 960. Cannula cover 992comprises a generally annular portion 1130 and a generally cylindricalportion 1132 extending distally therefrom. A bore 1134 extendsthroughout the full length of cannula cover 992 and along both theannular portion 1130 and through cylindrical portion 1132.

Bore 1134 comprises a proximal portion 1136 having a first diameter andextending along annular portion 1130 and a distal portion 1138 having asecond diameter, generally greater than the first diameter and extendingalong the cylindrical portion 1132.

A distally facing shoulder 1140 is formed between proximal portion 1136and distal portion 1138. The cylindrical portion 1132 defines a distallyfacing edge surface 1142.

It is also seen that a plurality of bores 1144 are formed through theannular portion 1130 of cannula cover 992, which extend along axes thatare parallel to longitudinal axis 960.

Reference is now made to FIGS. 59A and 59B, which are simplifiedpictorial illustrations of an exemplary embodiment of the cannula break994, forming part of the cannula assembly 940 of FIG. 45.

In some embodiments, cannula break 994 is generally an arc-shapedelement defining an inner surface 1150 and an outer surface 1152. Arecess 1154 is formed on the outer surface 1152.

Reference is now made to FIGS. 60A and 60B, which are simplified planarand sectional view illustrations of the cannula assembly 940 of FIG. 45.

It is seen in FIGS. 60A and 60B that the cannula cover 992 is fixedlyattached to cannula body 980 by pins 995, which are inserted into bores1144 of the cannula cover 992 and bores 1114 of the cannula body 980.The cylindrical portion 1132 of the cannula cover 992 lies withinproximal portion 1110 of the cannula body 980.

It is further seen particularly in FIG. 60B that cannula inner sleeve990 is mounted partially within cannula body 980 and partially withincannula cover 992, such that outer surface 1120 of cannula inner sleeve990 lies partially against intermediate portion 1108 of cannula body 980and partially against distal portion 1138 of cannula cover 992.

It is additionally seen that a plurality of cannula breaks 994 tightenthe inner sleeve 990 within the cannula body 980, in order tomomentarily stop rotation of inner sleeve 990 and thereby reverse thedirection of rotation. The cannula breaks 994 are tightened by pins 996,which are inserted into recesses 1154 formed in cannula breaks 994. Theinner surfaces 1150 of the breaks 994 lie against outer surface 1120 ofinner sleeve 990. The breaks 994 are disposed in the proximal portion1110 of the cannula body 980.

Reference is now made to FIGS. 61A and 61B, which are simplified planarand sectional view illustrations of an exemplary embodiment of the bonematerial removal device 900 and the cannula assembly 940 of FIGS. 44 and45 shown in the closed operative orientation partially inserted into abone of a patient.

It is seen in FIGS. 61A and 61B that cannula assembly 940 is mountedover bone material removal device 900, such that groove 1126 of innersleeve 990 engages tennon 930 that is mounted in tubular element 922.Tubular element 922 of bone material removal device 900 is partiallyinserted through cylindrical portion 1106 of cannula body 980, bore 1122of inner sleeve 990 and proximal portion 1136 of cannula cover 992 ofthe cannula assembly 940.

It is further seen in FIGS. 61A and 61B that an initial bore 1200 of afirst diameter is formed in the bone of the patient while drilling withthe bone material removal device 900 positioned in its closed operativeorientation. It is noted that this initial drilling is provided whilethe rotating element 902 is rotated in a first rotational direction, inthis exemplary embodiment, in a clockwise direction.

While the rotating element 902 rotates in a clockwise rotationaldirection, the pins 905 are prevented from being displaced along helicalpaths 970, thus preventing displacement of the guiding element 904distally, thereby the cutting tooth 952 remains closed and initial bore1200 of a first diameter is created in the bone of a patient.

Reference is now made to FIGS. 62A and 62B, which are simplified planarand sectional view illustrations of an exemplary embodiment of the bonematerial removal device 900 and the cannula assembly 940 of FIGS. 44 and45 shown in an open operative orientation partially inserted into a boneof the patient. Reference is additionally made to FIGS. 63A and 63B,which are simplified planar and sectional view illustrations of the bonematerial removal device 900 and the cannula assembly 940 of FIGS. 44 and45 shown in the open operative orientation while an undercut is createdwithin the bone of the patient.

It is particularly seen in FIGS. 62A and 62B that the direction ofrotation of the rotational element 902 is reversed and the bone materialremoval device 900 is now positioned in its open operative orientation,configured to create an undercut bore 1202 of a second diameter, whichis generally greater than the first diameter of initial bore 1200.

It is noted that once the direction of rotation of the rotating element902 is reversed, the tennon 930 that is mounted into tubular element 922is seated within groove 1126 of inner sleeve 990 of cannula assembly 940and due to press-fit engagement of cannula breaks 994 with inner sleeve990, friction force is created between the tubular element 922 and theinner sleeve 990, thus permitting stopping the rotational movement ofthe tubular element 922 momentarily in order to enable changing thedrilling rotational direction.

It is seen in FIGS. 62A - 63B that the undercut bore 1202 is formed overthe initial bore 1200, undercut bore 1202 having a second diameter,which is greater than the first diameter while drilling with the bonematerial removal device 900 positioned in its open operativeorientation. It is noted that this undercut bore drilling is providedwhile the rotating element 902 is rotated in a second rotationaldirection, in this exemplary embodiment, in a counter-clockwisedirection.

It is a particular feature of some embodiments of the present inventionthat once tennon 930 that is mounted into tubular element 922 is seatedwithin groove 1126 of inner sleeve 990 of cannula assembly 940, therotation of the tubular element 922 is momentarily stopped, therotational direction of the drilling can be reversed, thus causing thepins 905 to be displaced along helical path 970 formed in guidingelement 904, thus providing for distal longitudinal displacement ofguiding element 904, thereby pushing the shaft element 920 distally,which in turn causes pivoting of hinge element 954 and pivoting of tooth952 to assume its open operative orientation. The cutting tooth 952 canpivot up to 90 degrees from its initial orientation and protrude throughtip element 950.

The extent of longitudinal displacement of the shaft element 920 dependson the length of guiding slot 974 or the location of the stopper 912 inthis particular embodiment of the present invention, thus during theaxial displacement of shaft element 920 in a distal direction, theguiding pin 908 is displaced along the guiding slot 974 from itsproximal end to its distal end.

While the rotating element 902 and the tubular element 922 are rotatingin a counter-clockwise rotational direction, the cutting tooth 952engages the bone of the patient and creates undercut bore 1202 therein.It is noted that the cutting tooth 952 can be closed once the directionof rotation is reversed and the bone material removal device 900 can beadvanced and retracted to and from the bone of the patient in order tocreate the desired length of undercut bore 1202.

Reference is now made to FIGS. 64A and 64B, which are perspectivesimplified planar and sectional view illustrations of an exemplaryembodiment of the bone material removal device 900 and the cannulaassembly 940 of FIGS. 44 and 45 shown in the closed operativeorientation following removal from the bone of the patient.

It is appreciated that in order to return to the closed operativeorientation of the bone material removal device 900, direction ofdrilling rotation has to be changed using the friction created betweenthe tubular element 922 and the inner sleeve 990 due to brakes 994. Thisdrilling direction urges the pins 905 to be displaced in the oppositedirection along helical paths 970 of guiding element 904, thus urgingthe shaft element 920 to be displaced axially in a proximal direction,thus urging pivoting of the hinge element 954 and in turn pivoting ofthe cutting tooth 952 such that it is fully enclosed within tip element950. At this stage, the bone material removal device 900 can be removedfrom the bone of the patient and the resulting variable diameter bore,comprised of initial bore 1200 and undercut bore 1202, can be seen asillustrated in FIG. 64B.

Reference is now made to FIG. 65, which is a simplified pictorialillustration of a bone material removal device 1300, constructed andoperative in accordance with some embodiments of the present invention.

It is noted that bone material removal device 1300 is substantiallysimilar to bone material removal device 900 shown in FIG. 44 in allrespects other than the features that are described in detailhereinbelow. Similar elements are indicated by the same referencenumerals that are used for bone material removal device 900.

It is a particular feature of some embodiments of the present inventionthat bone material removal device 1300 provides for creating undercutbores of various diameters, by opening the cutting tooth to a differentradial extent as is described in detail hereinbelow.

It is noted that the following relations between the differentcomponents of the exemplary bone material removal device 1300 of FIG. 65are at least in part similar to the relations between the differentcomponents of the exemplary bone material removal device 900 of FIG. 44.

In some embodiments, the bone material removal device 1300 comprises arotating element 902 configured to be rotatably attached to a guidingelement 904 by means of pins 905. Guiding element 904 is in turnslidably attached to an adjustable body crank element 1306 by means ofguiding pin 908 and bearing crank 910.

It is noted that in some embodiments, an adjustable element 1302 isarranged to be mounted onto adjustable body crank element 1306 forselectably limiting axial displacement of guiding pin 908.

It is further noted that in some embodiments, a shaft element 920 isfixedly attached to guiding element 904 and a tubular element 922 isfixedly attached to adjustable body crank element 906 and surroundsshaft element 920. It is noted that a tennon 930 is configured to beinsertable into a groove 932 formed in the tubular element 922 forcooperation with a cannula assembly 940.

In some embodiments, a tip element 950 is attached or integrally madewith the tubular element 922. A tooth 952 is arranged to be connected tothe shaft element 920 by means of a hinge 954 and pivotably connected tothe tip element 950.

It is seen that in some embodiments, rotating element 902, guidingelement 904, adjustable body crank element 1306, bearing crank 910,adjustable element 1302, shaft element 920, tubular element 922 and tipelement 950 are all arranged along a single mutual longitudinal axis960.

It is additionally noted that cannula assembly 940 is configured to bemounted over the tubular element 922 and arranged along longitudinalaxis 960.

It is appreciated that the tubular element 922 is preferably made of abiocompatible material, e.g., titanium.

It is further noted, as described in detail hereinabove that the guidingelement 904 includes typically two helical paths 970 cooperating withtypically two pins 905 and an aperture 972 cooperating with guiding pin908. It is a particular feature of some embodiments of the presentinvention that the rotational displacement of pins 905 within helicalpath 970 of guiding element 940 is converted to a linear displacement ofguiding pin 908 within a slot formed in adjustable body crank element1306, thereby urging axial displacement of shaft element 920 alonglongitudinal axis 960. This longitudinal displacement of shaft element920, urges pivoting of hinge 954, and thereby causes pivoting of tooth952 relative to tip element 950.

The bone material removal device 1300 is shown in an assembled and openoperative orientation. Hinge 954 is hingedly attached by a pin withinrecess 1014 of shaft element 920, and the hinge 954 is additionallyhingedly attached to the cutting tooth 952, which is in this openoperative orientation of the bone material removal device 1300 fullyextends radially outwardly from tip element 950, since the shaft element920 is positioned in its distal position in this open operativeorientation. In this open operative orientation of bone material removaldevice 1300, the diameter of the bore formed in the bone of the patientis larger than the outer diameter of tip element 950.

It is a particular feature of some embodiments of the present inventionthat pins 905 are displaced along helical paths 970 of guiding element904, thus positioning the guiding element 904 in its distal position,the displacement of the guiding element 904 urges distal longitudinaldisplacement of shaft element 920, thus providing for pivoting of thehinge 954 and in turn pivoting of tooth 952 and positioning thereof inthe open operative orientation.

It is a further particular feature of some embodiments of the presentinvention that bone material removal device 1300 includes an adjusterelement 1302, which is configured to cooperate with an adjustable bodycrank element 1306, this cooperation enables opening the cutting tooth952 to various radial extends and thus forms various diameters ofundercut bores in the bone of the patient.

Reference is now made to FIG. 66, which is a simplified pictorialillustration of an exemplary embodiment of the body crank element 1306,forming part of the bone material removal device 1300 of FIG. 65.

It is seen in FIG. 66 that adjustable body crank element 1306 ispreferably longitudinal integrally made element having a proximal end1320, configured to be attached to bearing crank 910 and a distal end1322 configured to be attached to the tubular element 922.

The adjustable body crank element 1306 defines a hollow bore 1324therewithin for partial insertion of guiding element 904 at its proximalend and partial insertion of shaft element 920 at its distal end.

Adjustable body crank element 1306 preferably includes a proximalgenerally cylindrical portion 1330, an intermediate generallycylindrical portion 1332 and a distal generally cylindrical portion1334. The outer diameter of the distal portion 1334 is preferablysmaller than the outer diameter of the intermediate portion 1332, thediameter of which in turn is smaller than the outer diameter of theproximal portion 1330.

It is a particular feature of some embodiments of the present inventionthat a first outer threading 1340 is formed on the outer surface of thedistal portion 1334. Typically, two longitudinal grooves 1342 extend inparallel to longitudinal axis 960 along the distal portion 1334.

It is a further particular feature of some embodiments of the presentinvention that a second outer threading 1350 is formed on the outersurface of the intermediate portion 1332.

It is a yet further particular feature of some embodiments of thepresent invention that a marking scale 1360 is provided on the proximalportion 1330 of the adjustable body crank element 1306 for indicationthe undercut bore diameter formed in the bone of the patient, which issubstantially equal to the radial extent of cutting tooth 952 opening.

It is also seen that a longitudinal slot 1370 is formed in theadjustable body crank element 1306, at the proximal portion 1330 forguiding of guiding pin 908 therealong. The longitudinal slot 1370preferably extends through the marking scale 1360 in order to providevisual indication for the user of the bore diameter that is set up.

Reference is now made to FIGS. 67A, 67B and 67C, which are simplifiedpictorial illustration, end plan view and a section view of adjustingelement 1302,forming part of an exemplary embodiment of the bonematerial removal device 1300 of FIG. 65, section being taken along linesC-C in FIG. 67A.

Adjusting element 1302 is an integrally made generally cylindricalhollow element having a proximal end 1380 and a distal end 1382.

It is seen in FIGS. 67A-67C that longitudinal bore 1390 is formedthrough adjusting element 1302. The bore 1390 preferably includes aproximal portion 1392, an intermediate portion 1394 and a distal portion1396.

It is a particular feature of some embodiments of the present inventionthat an inner thread 1400 is formed on the intermediate portion 1394 ofthe bore 1390.

It is noted that in some embodiments, the diameter of the distal portion1396 is greater than the diameter of the intermediate portion 1394, suchthat a distally facing annular shoulder surface 1402 is formed betweenthe intermediate portion 1394 and distal portion 1396.

As particularly seen in FIG. 67B, a plurality of mutually radiallyspaced grooves 1410 are formed on annular shoulder surface 1402.

Reference is now made to FIG. 68, which is a simplified pictorialillustration of an embodiment of a disc element 1420, forming part of anexemplary embodiment of the bone material removal device 1300 of FIG.65.

Disc element 1420 is configured to cooperate with adjusting element1302. Disc element 1420 comprises a bore 1422 extending longitudinallyand at the center thereof and it defines a proximally facing annularsurface 1424. Typically, one, two or more mutually radially opposedprotrusions 1430 are formed on the proximally facing annular surface1424 and are configured to cooperate with groves 1410 formed onadjusting element 1302.

Reference is now made to FIG. 69, which is a simplified pictorialillustration of a nut element 1440, forms part of an exemplaryembodiment of the bone material removal device 1300 of FIG. 65.

It is seen in FIG. 69 that the nut element 1440 is integrally formed andcomprises a longitudinal bore 1442 extending at the center thereof. Thenut element 1440 defines a proximally facing surface 1444.

Reference is now made to FIGS. 70A and 70B, which are plan view andsection view illustrations of an exemplary embodiment of the bonematerial removal device 1300 of FIG. 65 shown in a partially openoperative orientation.

It is appreciated that most of the relations between the differentcomponents of bone material removal device 1300 is similar in theembodiments shown in FIGS. 70A and 70B and the embodiments shown inFIGS. 53A and 53B for example. The relations that are different fromthese shown in FIGS. 53A and 53B are described in detail hereinbelow.

The adjusting element 1302 is threadably mounted onto adjustable bodycrank element 1306 of bone material removal device 1300, by means ofengagement of inner threading 1400 of adjusting element 1302 with outerthreading 1350 of adjustable body crank element 1306.

It is seen in FIG. 70A that guiding pin 908 engages the proximal end1380 of adjusting element 1302 and additionally the guiding pin 908 isinserted through longitudinal slot 1370 of adjustable body crank element1306. The position of the guiding pin 908 along slot 1370 and relativeto the proximal end 1380 of adjusting element 1302 indicates the radialextent of the opening of cutting tooth 952, by means of marking scale1360, which is provided on adjustable body crank element 1306.

It is seen particularly in the embodiment shown in FIG. 70B that discelement 1420 is mounted on distal portion 1334 of adjustable body crankelement 1306, such that the radially inwardly facing ends of protrusions1430 of disc element 1420 are guided within grooves 1342 of adjustablebody crank element 1306.

It is a particular feature of some embodiments of the present inventionthat the plurality of protrusions 1430 of disc element 1420 areregistered with the plurality of grooves 1410 formed on adjustingelement 1302.

A nut element 1410 is threadably mounted onto outer threading 1340 ofadjustable body crank element 1306.

It is further seen in FIG. 70B that a compression spring 1470 issupported between the distally facing surface of disc element 1420 andproximally facing surface 1444 of the nut element 1410.

It is a particular feature of some embodiments of the present inventionthat upon rotation of the adjusting element 1302 relative to adjustablebody crank element 1306, and due to the threadable engagementtherebetween, the displacement of the guiding pin 908 withinlongitudinal slot 1370 of the adjustable body crank element 1306 iscontrolled, since the guiding pin 908 is supported on the proximal end1380 of adjusting element 1302. Upon rotation of the adjusting element1302, the adjusting element is translated axially along longitudinalaxis 960 due to its threadable engagement with the adjustable body crankelement 1306. The further the adjusting element 1302 is translateddistally, the further the guide pin 908 can be translated within thelongitudinal slot 1370 towards the distal end of slot 1370. The guidepin 908 is rigidly coupled to the guiding element 904, which is in turnconnected to shaft element 920, which is hingedly connected to thecutting tooth 952, thus the extent of radial pivoting of the cuttingtooth 952 depends on the axial position of the guiding pin 908 withinslot 1370 of the adjustable body crank element 1306. It is thusparticularly appreciated that rotation of adjusting element 1302controls the extent of radial pivoting of the cutting tooth 952.

It is a further particular feature of some embodiments of the presentinvention that a particular increment of rotation of the adjustingelement 1302 is defined by registration of the protrusions 1430 of discelement 1420 with grooves 1410 of the adjusting element 1302, whereasthe disc element 1420 is biased to engage the distally facing surface1402 of adjusting element 1302 by the force of spring 1470. Uponrotation of the adjusting element 1302, the disc element 1420 isdisplaced axially distally against the force of spring 1470, whileguided by grooves 1342 of the adjustable body crank element 1306. Thethreading of the adjusting element 1302 relative to the adjustable bodycrank element 1306 is divided into a plurality of increments, eachincrement is completed once protrusion 1430 of disc element 1420 isseated within the successive groove 1410 of adjusting element 1302. Thisdivision to increments enables accurate determination of the diameter ofundercut bore created in the bone of the patient, while the user can seethis determined diameter using the marking scale 1360 provided on theadjustable body crank element 1306. When the desired bore diameter isdetermined by rotation of the adjusting element 1302 relative theadjustable body crank element 1306, the displacement of the guiding pin908 within slot 1370 is limited and thus the distal displacement ofshaft element 920 is limited, thereby pivoting the cutting tooth 952using the hinge element 954 only to a certain extent, rather than fullyopening the cutting tooth 952.

It is a further particular feature of some embodiments of the presentinvention that spring 1470 is operative to bias the disc element 1420proximally, towards grooves 1410 of adjustable element 1302, thereby theprotrusions 1430 are firmly seated in one of a plurality of grooves 1410while providing tactile indication of this insertion to the user andthereby avoiding inadvertent change of drilling diameter.

It is seen in this particular example shown in FIGS. 70A and 70B thatthe adjusting element 1320 is slightly rotated with respect toadjustable body crank element 1306, such that the inner threading 1400of adjusting element 1302 is disposed slightly distally to the proximalend of the outer threading 1350 of the adjustable body crank element1306, thus the guiding pin 908 is slightly displaced distally along slot1370 and the marking scale 1360 indicates diameter of 7mm in thisparticular example. It is seen that in this operative orientation, thecutting tooth 952 is only partially open, it is pivoted such that thecutting tooth 952 extends radially at an acute angle with respect tolongitudinal axis 960.

Reference is now made to FIGS. 71A and 71B, which are simplified planarand sectional view illustrations of an exemplary embodiment of the bonematerial removal device 1300 and the cannula assembly 940 of FIGS. 65and 45 shown in the closed operative orientation inserted into a bone ofa patient.

It is seen in this particular example shown in FIGS. 71A and 71B thatthe adjusting element 1320 is not rotated with respect to adjustablebody crank element 1306, thus the guiding pin 908 is disposed at theproximal end of slot 1370 and the marking scale 1360 is not seen in thisoperative orientation. It is seen that in this operative orientation,the cutting tooth 952 is fully closed.

It is seen in FIGS. 71A and 71B that cannula assembly 940 is mountedover bone material removal device 1300, such that groove 1126 of innersleeve 990 engages tennon 930 that is mounted in tubular element 922.Tubular element 922 of bone material removal device 900 is partiallyinserted through cylindrical portion 1106 of cannula body 980, bore 1122of inner sleeve 990 that extends throughout the cannula body 980 andproximal portion 1136 of cannula cover 992 of the cannula assembly 940.

It is further seen in FIGS. 71A and 71B that an initial bore 1500 of afirst diameter is formed in the bone of the patient while drilling withthe bone material removal device 1300 positioned in its closed operativeorientation. It is noted that this initial drilling is provided whilethe rotating element 902 is rotated in a first rotational direction, inthis exemplary embodiment, in a clockwise direction.

While the rotating element 902 rotates in a clockwise rotationaldirection, the pins 905 are prevented from being displaced along helicalpaths 970, thus preventing displacement of the guiding element 904distally, thereby the cutting tooth 952 remains closed and initial bore1500 of a first diameter is created in the bone of a patient.

Reference is now made to FIGS. 72A and 72B, which are simplified planarand sectional view illustrations of an exemplary embodiment of the bonematerial removal device 1300 and the cannula assembly 940 of FIGS. 65and 45 shown in a first partially open operative orientation insertedinto a bone of the patient.

It is seen in this particular example shown in FIGS. 72A and 72B thatthe adjusting element 1320 is slightly rotated with respect toadjustable body crank element 1306, such that the inner threading 1400of adjusting element 1302 is disposed slightly distally to the proximalend of the outer threading 1350 of the adjustable body crank element1306, thus the guiding pin 908 is slightly displaced distally along slot1370 and the marking scale 1360 indicates diameter of 7mm in thisparticular example. It is seen that in this operative orientation, thecutting tooth 952 is only partially open, it is pivoted such that thecutting tooth 952 extends radially at an acute angle with respect tolongitudinal axis 960.

It is particularly seen in FIGS. 72A and 72B that the direction ofrotation of the rotational element 902 is reversed and the bone materialremoval device 1300 is now positioned in its partially open operativeorientation, configured to create an undercut bore 1502 of a seconddiameter, which is generally greater than the first diameter of initialbore 1500.

It is noted that once the direction of rotation of the rotating element902 is reversed, the tennon 930 that is mounted into tubular element 922is seated within groove 1126 of inner sleeve 990 of cannula assembly 940and due to press-fit engagement of cannula breaks 994 with inner sleeve990, friction force is created between the tubular element 922 and theinner sleeve 990, thus permitting stopping the rotational movement ofthe tubular element 922 momentarily in order to enable changing thedrilling rotational direction.

It is seen in FIGS. 72A and 72B that the undercut bore 1502 is formedover the initial bore 1500, undercut bore 1502 having a second diameter,which is greater than the first diameter while drilling with the bonematerial removal device 1300 positioned in its partially open operativeorientation. It is noted that this undercut bore drilling is providedwhile the rotating element 902 is rotated in a second rotationaldirection, in this exemplary embodiment, in a counter-clockwisedirection.

It is a particular feature of some embodiments of the present inventionthat once tennon 930 that is mounted into tubular element 922 is seatedwithin groove 1126 of inner sleeve 990 of cannula assembly 940, therotation of the tubular element 922 is momentarily stopped, therotational direction of the drilling can be reversed, thus causing thepins 905 to be displaced along helical path 970 formed in guidingelement 904, thus providing for distal longitudinal displacement ofguiding element 904, thereby pushing the shaft element 920 distally,which in turn causes pivoting of hinge element 954 and pivoting of tooth952 to assume its partially open operative orientation. It is aparticular feature of some embodiments of the present invention that theguiding element 904 is distally advanced only up to the point where theguiding pin 908 is limited by the adjusting element 1302, thus thecutting tooth 952 in this operative orientation pivots up to an acuteangle phi1 and protrudes through tip element 950, such as to form anundercut bore 1502 of 7 mm in this particular example.

The extent of longitudinal displacement of the shaft element 920 dependson the position of guiding pin 908 along slot 1370 of adjustable bodycrank element 1306, which is limited by engagement with adjustingelement 1302. During the axial displacement of shaft element 920 in adistal direction, the guiding pin 908 is displaced along slot 1370 fromits proximal end up to the point where the pin 908 engages the proximalend 1380 of adjusting element 1302.

While the rotating element 902 and the tubular element 922 are rotatingin a counter-clockwise rotational direction, the cutting tooth 952engages the bone of the patient and creates undercut bore 1502 therein.It is noted that the cutting tooth 952 can be closed once the directionof rotation is reversed and the bone material removal device 1300 can beadvanced and retracted to and from the bone of the patient in order tocreate the desired length of undercut bore 1502.

Reference is now made to FIGS. 73A and 73B, which are simplified planarand sectional view illustrations of an exemplary embodiment of the bonematerial removal device 1300 and the cannula assembly 940 of FIGS. 65and 45 shown in a second partially open operative orientation insertedinto a bone of the patient.

It is seen in this particular example shown in FIGS. 73A and 73B thatthe adjusting element 1302 is slightly more rotated with respect toadjustable body crank element 1306 than in FIGS. 72A and 72B, such thatthe inner threading 1400 of adjusting element 1302 is disposed slightlydistally in comparison to its position as shown in FIGS. 72A and 72B,thus the guiding pin 908 is slightly displaced distally along slot 1370and the marking scale 1360 indicates diameter of 8mm in this particularexample. It is seen that in this operative orientation, the cuttingtooth 952 is only partially open, but more so than in FIGS. 72A and 72B,it is pivoted such that the cutting tooth 952 extends radially at anacute angle with respect to longitudinal axis 960.

It is particularly seen in the embodiment shown in FIGS. 73A and 73Bthat the cutting tooth 952 is configured to create an undercut bore 1504of a third diameter, which is generally greater than the first and thesecond diameter.

It is seen in the embodiment shown in FIGS. 73A and 73B that theundercut bore 1504 is formed over the initial bore 1500, undercut bore1504 having a third diameter, which is greater than the first diameterand the second diameter while drilling with the bone material removaldevice 1300 positioned in its partially open operative orientation. Itis noted that this undercut bore drilling is provided while the rotatingelement 902 is rotated in a second rotational direction, in thisexemplary embodiment, in a counter-clockwise direction.

It is a particular feature of some embodiments of the present inventionthat once tennon 930 that is mounted into tubular element 922 is seatedwithin groove 1126 of inner sleeve 990 of cannula assembly 940, therotation of the tubular element 922 is momentarily stopped, therotational direction of the drilling can be reversed, thus causing thepins 905 to be displaced along helical path 970 formed in guidingelement 904, thus providing for distal longitudinal displacement ofguiding element 904, thereby pushing the shaft element 920 distally,which in turn causes pivoting of hinge element 954 and pivoting of tooth952 to assume its partially open operative orientation. It is aparticular feature of some embodiments of the present invention that theguiding element 904 is distally advanced only up to the point where theguiding pin 908 is limited by the adjusting element 1302, thus thecutting tooth 952 in this operative orientation pivots up to an acuteangle phi2 and protrudes through tip element 950, such as to form anundercut bore 1504 of 8mm in this particular example.

The extent of longitudinal displacement of the shaft element 920 dependson the position of guiding pin 908 along slot 1370 of adjustable bodycrank element 1306, which is limited by engagement with adjustingelement 1302. During the axial displacement of shaft element 920 in adistal direction, the guiding pin 908 is displaced along slot 1370 fromits proximal end up to the point where the pin 908 engages the proximalend 1380 of adjusting element 1302.

While the rotating element 902 and the tubular element 922 are rotatingin a counter-clockwise rotational direction, the cutting tooth 952engages the bone of the patient and creates undercut bore 1504 therein.It is noted that the cutting tooth 952 can be closed once the directionof rotation is reversed and the bone material removal device 1300 can beadvanced and retracted to and from the bone of the patient in order tocreate the desired length of undercut bore 1504.

Reference is now made to FIGS. 74A and 74B, which are simplified planarand sectional view illustrations of an exemplary embodiment of the bonematerial removal device 1300 and the cannula assembly 940 of FIGS. 65and 45 shown in a fully open operative orientation inserted into a boneof the patient.

It is seen in this particular example shown in FIGS. 74A and 74B thatthe adjusting element 1302 is slightly more rotated with respect toadjustable body crank element 1306 than in FIGS. 73A and 73B, such thatthe inner threading 1400 of adjusting element 1302 is disposed slightlydistally in comparison to its position as shown in FIGS. 73A and 73B,thus the guiding pin 908 is slightly displaced distally along slot 1370and the marking scale 1360 indicates diameter of 9mm in this particularexample. It is seen that in this operative orientation, the cuttingtooth 952 is now fully open, it is pivoted such that the cutting tooth952 extends transversely with respect to longitudinal axis 960.

It is particularly seen in FIGS. 74A and 74B that the cutting tooth 952is configured to create an undercut bore 1506 of a fourth diameter,which is generally greater than the first, the second and the thirddiameter.

It is seen in FIGS. 74A and 74B that the undercut bore 1506 is formedover the initial bore 1500, undercut bore 1506 having a fourth diameter,which is greater than the first, the second and the third diameter whiledrilling with the bone material removal device 1300 positioned in itsfully open operative orientation. It is noted that this undercut boredrilling is provided while the rotating element 902 is rotated in asecond rotational direction, in this exemplary embodiment, in acounter-clockwise direction.

It is a particular feature of some embodiments of the present inventionthat once tennon 930 that is mounted into tubular element 922 is seatedwithin groove 1126 of inner sleeve 990 of cannula assembly 940, therotation of the tubular element 922 is momentarily stopped, therotational direction of the drilling can be reversed, thus causing thepins 905 to be displaced along helical path 970 formed in guidingelement 904, thus providing for distal longitudinal displacement ofguiding element 904, thereby pushing the shaft element 920 distally,which in turn causes pivoting of hinge element 954 and pivoting of tooth952 to assume its fully open operative orientation. It is a particularfeature of some embodiments of the present invention that the guidingelement 904 is distally advanced only up to the point where the guidingpin 908 is limited by the adjusting element 1302, thus the cutting tooth952 in this operative orientation pivots up to a straight angle phi3 andprotrudes through tip element 950, such as to form an undercut bore 1506of 9mm in this particular example, which is the maximal diameter thatcan be formed using the particular cutting tooth 952 of this particularexample. It is appreciated that any tooth configuration can be usedwhich provides for any other range of diameters. It is also noted thatthe particular range of diameters exemplified in FIGS. 72A-74B is notlimiting the scope of the present invention, any range of diameters canbe formed using bone material removal device 1300.

The extent of longitudinal displacement of the shaft element 920 dependson the position of guiding pin 908 along slot 1370 of adjustable bodycrank element 1306, which is limited by engagement with adjustingelement 1302. During the axial displacement of shaft element 920 in adistal direction, the guiding pin 908 is displaced along slot 1370 fromits proximal end up to the point where the pin 908 engages the proximalend 1380 of adjusting element 1302.

While the rotating element 902 and the tubular element 922 are rotatingin a counter-clockwise rotational direction, the cutting tooth 952engages the bone of the patient and creates undercut bore 1504 therein.It is noted that the cutting tooth 952 can be closed once the directionof rotation is reversed and the bone material removal device 1300 can beadvanced and retracted to and from the bone of the patient in order tocreate the desired length of undercut bore 1506.

A bone material removal device is disclosed herein, which isparticularly useful for drilling a small diameter bore with varyingdiameters.

Reference is now made to FIG. 75, which is a simplified exploded viewillustration of a bone material removal device constructed and operativein accordance with an embodiment of the present invention.

It is seen in FIG. 75 that a bone material removal device 10000 includesa rotating element 10200 at its proximal end, a connecting tube 10400adapted to be distally attached thereto or integrally made therewith anda drill tube 10600 adapted to be distally attached to connecting tube10400 or integrally made therewith.

A drilling tip 10800 is adapted to be connected or integrally formedwith drill tube 10600.

An activating rod 11000 is adapted to be coaxially arranged within therotating element 10200, connecting tube 10400 and drill tube 10600.

As shown in FIG. 75, the bone material removal device 10000 comprises ashaft displacement actuator comprising a rotating element 10200coupledto an eccentric rotatable mass, e.g., a flywheel, rotatingly andslidingly coupled to bushing 11200 and limiting screws 11400. Theactivating rod 11000 is adapted to be inserted into the rotating element10200 and slidably attached to rotating element 10200 by means of abushing 11200 and limiting screws 11400. The limiting screws 11400extend generally radially with respect to activating rod 11000 andprotrude through an eccentric rotatable mass 11600, which is mountedonto the rotating element 10200. In some embodiments, the rotatableeccentric mass comprises a flywheel.

It is additionally seen that generally two locking rings 11800 aredisposed at each side of bushing 11200 and a resilient element, such asa coil spring 12000 is generally adapted to be disposed partially withinthe rotating element 10200 and partially within connecting tube 10400.

Reference is now made to FIG. 76, which is a simplified pictorial sideview illustration of the rotating element 10200 of the bone materialremoval device 10000 of FIG. 75.

It is seen in FIG. 76 and additionally seen in FIGS. 82A and 83A thatthe rotating element 10200 is a generally cylindrical element arrangedalong a longitudinal axis 12100.

Rotating element 10200 has a distal end, which is adapted to beconnected to a power tool and a proximal end, which is adapted to beattached to connecting tube 10400. Rotating element 10200 has aninternal socket 13000 extending distally from its proximal end.

It is additionally seen in FIG. 76 that typically two circumferentialguiding slots 13200 are arranged on the rotating element 10200 adjacentthe proximal end thereof. The guiding slots 13200 are generally orientedin opposite directions.

Reference is now made to FIG. 77, which is a simplified pictorial sideview illustration of the connecting tube 10400 of the bone materialremoval device 10000 of FIG. 75.

It is seen in FIG. 77 and additionally seen in FIGS. 82A and 83A thatthe connecting tube 10400 is a generally cylindrical element arrangedalong longitudinal axis 12100.

Connecting tube 10400 has a distal end, which is adapted to be connectedto the rotating element 10200 and a proximal end, which is adapted to beattached to drill tube 10600.

Connecting tube 10400 has an internal socket 13600 extending distallyfrom its proximal end for attachment of the drill tube 10600. Connectingtube 10400 additionally has an internal socket 13800 extendingproximally from its distal end for supporting one end of spring 12000.

Reference is now made to FIG. 78, which is a simplified pictorial sideview illustration of the drill tube 10600 of the bone material removaldevice 10000 of FIG. 75.

It is seen in FIG. 78 and additionally seen in FIGS. 82A and 83A thatthe drill tube 10600 is a generally cylindrical element arranged alonglongitudinal axis 12100. Drill tube 10600 has a distal end, which isadapted to be connected to the rotating element 10200 and a proximalend, which is adapted to be attached to connecting tube 10400. Thedrilling tube has a longitudinal bore 14000 extending therethrough.

It is additionally seen that the drill tube 10600 has a main portion14200 having a first outer diameter and a proximal portion 14400 havinga second diameter, generally smaller than the first diameter.

It is seen that a slot 14600 is generally formed in proximal portion14400.

Reference is now made to FIG. 79, which is a simplified pictorial sideview illustration of the activating rod 11000 of the bone materialremoval device 10000 of FIG. 75.

It is seen in FIG. 79 and additionally seen in FIGS. 82A and 83A thatthe activating rod 11000 is a generally cylindrical element arrangedalong longitudinal axis 12100.

Activating rod 11000 has a distal end having typically twocircumferential recesses 15000 formed thereon and spaced one from eachother. The recesses 15000 are adapted for mounting of locking rings11800 therewithin in order to lock the bushing 11200 to the activatingrod 11000.

It is additionally seen in FIG. 78 that an activating tip 15200protrudes proximally from the proximal end of the activating rod 11000.The activating tip 15200 defines a proximally facing shoulder 15400therebetween and between the distal end of the activating rod 11000. Theactivating tip 15200 has a generally rounded distal tip 15600 and agenerally flat surface 15800 between the rounded activating tip 15200and shoulder 15400.

Reference is now made to FIGS. 80A and 80B, which are simplified twodifferent side view illustrations of the drilling tip 10800 of the bonematerial removal device 10000 of FIG. 75.

It is seen in FIGS. 80A and 80B and additionally seen in FIGS. 82A and83A that the drilling tip 10800 is a generally cylindrical elementarranged along longitudinal axis 12100. Drilling tip 10800 has a sharpproximal end 16000 and a main portion 16200 adapted to be inserted intoand attached to the drill tube 10600. A distal portion 16400 of thedrilling tip 10800 defines a generally flat surface 16600 and a slightlyrounded distal end 16800.

It is particularly seen that a cutting tooth 17000 is disposed on asurface located opposite to surface 16600 and protrudes radiallyoutwardly therefrom. It is appreciated that alternatively a plurality ofcutting teeth 17000 may be disposed on the drilling tip 10800.

It is appreciated that in an un-stressed position the distal portion16400 of the drilling tip 10800 is deflected, as particularly shown inFIG. 82A.

Reference is now made to FIG. 81, which is a simplified side viewillustration of the eccentric mass, (e.g., flywheel) 11600 of the bonematerial removal device 10000 of FIG. 75.

It is seen in FIGS. 75, 81, 82A-B and 83A-B that eccentric mass 11600 isa ring-shaped element having a longitudinally extending bore 18000extending therethrough for mounting the eccentric mass 11600 ontorotating element 10200. It is seen particularly in FIG. 81 that bore18000 is arranged along a longitudinal axis 12300, which is offset fromlongitudinal axis 12100.

It is noted that typically two radially extending bores 18200 (seen inFIG. 75) extend through eccentric mass 11600 for insertion of limitingscrews 11400 therethrough.

Reference is now made to FIGS. 82A and 82B, which are simplifiedrespective pictorial and sectional view illustrations of the bonematerial removal device 10000 of FIG. 75 shown in a first closedoperative drilling orientation.

The bone material removal device 10000 is shown in a closed operativedrilling orientation in FIGS. 82A-B.

It is seen that connecting tube 10400 is attached to rotating element10200 and drill tube 10600 is attached to connecting tube 10400, suchthat the distal end of drill tube 10600 is inserted into socket 13600 ofconnecting tube 10400.

Drilling tip 10800 is attached to the proximal end of the drill tube10600. Activating rod 11000 is inserted into the drill tube 10600 anddrilling tip 10800 is attached to the drill tube 10600, such that distalportion 16400 of drilling tip 10800 is in the non-stressed position andthe cutting tooth 17000 is contained within the diameter of the proximalportion 14400 of drill tube 10600. In this orientation, the cuttingtooth 17000 is located adjacent slot 14600 but does not protrudetherethrough.

The proximal end 15200 of the activating rod 11000 is positionedadjacent the distal portion 16400 of drilling tip 10800, such that roundtip 15600 of activating rod 11000 abuts rounded tip 16800 of drillingtip 10800.

It is additionally seen in FIG. 82B that bushing 11200 is retained onactivating rod 11000 by locking rings 11800 positioned within recesses15000. Limiting screws 11400 protrude from the bushing 11200 throughguiding slots 13200 in the rotating element 10200 and through bores18200 in the eccentric mass 11600.

Spring 12000 is disposed between the proximal locking ring 11800 and thedistally facing surface of socket 13800 of the connecting tube 10400.The spring 12000 is positioned in a normally un-stressed operativeorientation in this closed operative orientation of the bone materialremoval device 10000. The bushing 11200 is slightly proximally spacedfrom the proximally facing surface of socket 13000 of the rotatingelement 10200.

It is a particular feature of an embodiment of the present inventionthat the distal portion 16400 of the drilling tip 10800 is positioned ina normally radially inwardly deflected orientation, such that thecutting tooth 170 is contained within the inner volume of the drill tube10600.

It is a particular feature of an embodiment of the present inventionthat once the bone material removal device 10000 is rotated in a firstrotational direction, limiting screws 11400 are positioned at one end ofthe circumferential slots 13200 and prevented from further radialmovement, thus the activating rod 11000 is positioned in a retractedposition, in which the spring 12000 is released and the flat surface15800 of activating rod 11000 does not engage flat surface 16600 of thedrilling tip 10800, thus the cutting tooth 17000 remains containedwithin the inner volume of drill tube 10600 and the bone materialremoval device 10000 is positioned in a closed operative orientation.

Reference is now made to FIGS. 83A and 83B, which are simplifiedrespective pictorial and sectional view illustrations of the bonematerial removal device 10000 of FIG. 75 shown in a second openoperative drilling orientation.

The bone material removal device 10000 is shown in an open operativedrilling orientation in FIGS. 83A-B.

It is seen that connecting tube 10400 is attached to rotating element10200 and drill tube 10600 is attached to connecting tube 10400, suchthat the distal end of drill tube 10600 is inserted into socket 13600 ofconnecting tube 10400.

Drilling tip 10800 is attached to the proximal end of the drill tube10600. Activating rod 11000 is inserted into the drill tube 10600 anddrilling tip 10800 is attached to the drill tube 10600, such that distalportion 16400 of drilling tip 10800 is positioned in a stressed positionin this open orientation, such that the cutting tooth 170 protrudesthrough slot 14600 formed in proximal portion 14400 of drill tube 10600.The cutting tooth 17000 protrudes through slot 14600 due to the factthat the activating rod 11000 is displaced proximally, the spring 12000is compressed and the proximal portion 15200 of the activating rod 11000slides under the distal portion 16400 of the drilling tip 10800, bymeans of engagement of rounded tip 16800 of the drilling tip 10800 androunded tip 15600 of actuating rod 11000. Once flat surface 15800 ofactivating rod 11000 abuts flat surface 16600 of drilling tip 10800, thedistal portion 16400 is deflected radially outwardly and the cuttingtooth 17000 protrudes through slot 14600 of drill tube 10600.

It is a particular feature of an embodiment of the present inventionthat once the bone material removal device 10000 is rotated in a secondrotational direction, which is opposite to the first rotationaldirection, the eccentric mass 11600 is rotated and due to centrifugalforce exertion, limiting screws 11400 are positioned at an opposite endof the circumferential slots 13200 and prevented from further radialmovement, thus the activating rod 11000 is displaced to an advancedposition, in which the spring 12000 is compressed and the flat surface15800 of activating rod 11000 engages flat surface 16600 of the drillingtip 10800, thus the cutting tooth 17000 is radially outwardly deflectedto protrude from the inner volume of drill tube 10600 and the bonematerial removal device 10000 is positioned in an open operativeorientation.

In an alternative embodiment, the activating rod 11000 may be displacedproximally manually in order to outwardly deflect the cutting tooth17000, such that it protrudes from the inner volume of drill tube 10600and the bone material removal device 10000 is positioned in an openoperative orientation.

It is additionally seen in FIG. 83B that bushing 11200 is retained onactivating rod 11000 by locking rings 11800 positioned within recesses15000. Limiting screws 11400 protrude from the bushing 11200 throughguiding slots 13200 in the rotating element 10200 and through bores 182in the eccentric mass 11600.

Spring 12000 is disposed between the proximal locking ring 11800 and thedistally facing surface of socket 13800 of the connecting tube 10400.The spring 12000 is positioned in a compressed operative orientation inthis open operative orientation of the bone material removal device10000. The bushing 11200 is slightly more proximally spaced from theproximally facing surface of socket 130 of the rotating element 10200 ascompared to the bushing position in FIG. 82B.

Reference is now made to FIG. 84, which is a simplified partialsectional view illustration of the bone material removal device 10000 ofFIG. 75 shown in the first closed operative drilling orientation withinthe bone of a patient and to FIG. 85, which is a simplified partialsectional view illustration of the bone material removal device 10000 ofFIG. 75 shown in the second open operative drilling orientation withinthe bone of a patient.

Reference is additionally made to FIG. 86, which is a simplified partialsectional view illustration of the patient bone following removal of thebone material removal device.

It is a particular feature of an embodiment of the present inventionthat the cutting tooth 17000 is at least partially contained within theinner volume of the drill tube 10600 and is selectively positioned in aclosed position enabling drilling a bore of a first diameter within thebone of a patient and in an open position enabling drilling a bore of asecond diameter within the bone of a patient, whereas the first diameteris preferably equal to the outer diameter of the drill tube 10600 andsecond diameter is preferably greater than the first diameter, thus anundercut is formed within the bone of a patient.

It is appreciated that biological material, such as a medicament may beretained within this cavity.

It is seen particularly in FIG. 84 that an initial bore 20000 of a firstdiameter is formed within the bone 20200 of a patient.

The radius of the initially drilled bore can be for example in the rangeof 0.5 mm-1 mm or any other radius, preferably equal to the outerdiameter of drill tube 10600.

It is a particular feature of an embodiment of the present inventionthat in the open operative orientation of the bone material removaldevice 10000, the cutting tooth 17000 extends radially outwardly fromthe outer diameter of the drill tube 10600. Thus, the drilling radiusformed by the cutting tooth 17000 is substantially greater than thedrilling radius initially formed by the outer diameter of the drill tube10600.

It is seen particularly in FIG. 85 that an undercut 20400 having asecond diameter is formed over the initial bore 20000 of a firstdiameter in the bone 20200 of a patient, whereas the second diameter issubstantially greater than the first diameter.

The radius of the undercut can be for example in the range of 0.75mm-1.25 mm

It is a further particular feature of an embodiment of the presentinvention that the length of the undercut 20400 formed in the bone 20200of a patient is a function of the length of the cutting tooth 17000 ofthe drilling tip 10800.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention.

Certain features described in the context of various embodiments are notto be considered essential features of those embodiments, unless theembodiment is inoperative without those elements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

What is claimed is:
 1. A bone material removal device, comprising: atubular element comprising a proximal end and a distal end; a shaftreceived within said tubular element and comprising a proximal end and adistal end; a cutting tooth movably coupled to said distal end of saidshaft; and a shaft displacement actuator at said proximal end of saidtubular element rotatably coupled to said shaft, wherein said actuatorcomprises a rotatable coupling comprising at least one slot in a wall ofsaid tubular element proximal end, said slot having a longitudinal axis,said axis being at an angle between 10 and 40 degrees in respect to saidshaft; wherein at least partial rotation of said actuator in a firstdirection brings said cutting tooth to travel from a closed retractedposition to an open extended position.
 2. A bone material removal deviceaccording to claim 1, wherein said tubular element proximal end isattached to said shaft via a pin-in-slot coupling.
 3. A bone materialremoval device according to claim 1, wherein said angle determines theratio of axial displacement of said shaft in respect to amount ofrotation of said actuator.
 4. A bone material removal device accordingto claim 1, wherein said slot comprises an at least partially spiralgeometry.
 5. A bone material removal device according to claim 1,wherein said coupling comprises a slot that extends the full thicknessof said tubular element wall.
 6. A bone material removal deviceaccording to claim 1, wherein said coupling comprises a threaded portionat said proximal end of said shaft interthreaded with a threaded portionof said actuator.
 7. A bone material removal device according to claim1, wherein said actuator comprises at least one eccentric rotatablemass.
 8. A bone material removal device according to claim 7, whereinsaid rotatable eccentric mass comprises a flywheel.
 9. A bone materialremoval device according to claim 1, wherein said cutting toothcomprises at least one resilient portion, and wherein at least a portionof said cutting tooth engages said tubular element via said resilientportion.
 10. A bone material removal device according to claim 9,wherein said cutting tooth engages said distal end of said tubularelement via said resilient portion of said cutting tooth, said resilientportion exerts constant bias in a radially inward direction that resistsoutward radial extension of the cutting tooth.
 11. A bone materialremoval device according to claim 9, wherein said cutting toothcomprises at least one leaf spring portion configured for biasing saidcutting tooth to said closed retracted position.
 12. A bone materialremoval device according to claim 9, wherein said cutting toothcomprises a base and a resiliently cantilevered arm supporting a cuttingedge.
 13. A bone material removal device according to claim 12, whereinsaid cantilevered arm is arced radially inwards to interfere with thepath of axial distal displacement of said shaft.
 14. A bone materialremoval device according to claim 1, wherein said cutting toothcomprises a base and a resiliently cantilevered arm supporting a cuttingedge, said cantilevered arm is arced radially inwards to interfere witha path of axial distally directed displacement of said shaft, andwherein said arced radially inwards position comprises a resting stateof said cantilevered arm.
 15. A bone material removal device accordingto claim 14, wherein forcing said arm radially outwardly places said armin a loaded-stressed position.
 16. A bone material removal deviceaccording to claim 14, wherein said shaft comprises a tapered end; andwherein axial proximal displacement of said shaft withdraws said tapereddistal end proximally from under said cantilevered loaded-stressed armbringing said arm to return to its rest unstressed position withdrawingsaid tooth cutting edge into said tubular element.
 17. A bone materialremoval device according to claim 14, wherein axial proximaldisplacement of the shaft moves said shaft tapered end from under theangled surface of said cutting tooth.
 18. A bone material removal deviceaccording to claim 14, wherein a distal end of said cantilevered arm isattached to said base portion and said arm is arced proximally radiallyinwards.
 19. A bone material removal device according to claim 14,wherein said shaft rests on an inside surface of said tubular elementand supports said cantilevered arm and said cutting tooth.
 20. A bonematerial removal device according to claim 16, wherein radially inwardlydirected bias exerted on said cutting tooth drives said tooth radiallyinward into said lumen of said tubular element once said shaft has beenwithdrawn axially proximally.
 21. A bone material removal deviceaccording to claim 1, wherein at least partial rotation of said actuatordisplaces said shaft axially; wherein said cutting tooth is positionedin said tubular element distal end to interfere with a path of axialdisplacement of said shaft; and wherein at least partial rotation ofsaid actuator in a first direction displaces said shaft axially distallyrelative to said tubular element, said axially displaced shaft, beingengaged with at least a portion of said cutting tooth, brings said toothto travel from said closed retracted position to said open extendedposition in which at least a portion of said cutting tooth extends in aradial direction beyond an outside surface of said tubular element. 22.A bone material removal device according to claim 1, also comprising acannula body having a bore extending throughout the length of thecannula configured to rotatingly receive at least a portion of saidtubular element, wherein said cannula body comprises at least one breakthat stops rotation of said tubular element inside said bore whenactuated.
 23. A bone material removal device according to claim 1,wherein said shaft displacement actuator is moveably coupled to saidtubular element proximal end and comprises an eccentric rotatable massthat movably couples said tubular element to said shaft via pinsconfigured to travel along a slot in a wall of said tubular element,said slot being angled in respect to said shaft, and wherein at leastpartial rotation of said eccentric rotatable mass in a first directioneffects a force that moves said pins within said slot from a firstposition to a second position and brings said cutting tooth to travelfrom a closed retracted position to an open extended position.
 24. Abone material removal device according to claim 1, further comprising: arotating body operatively attached to said proximal end of said tubularelement and comprising an inner threading; wherein said shaft comprisesa threaded portion engageable with said inner threading; wherein saidcutting tooth is operatively pivotably connected to said tubularelement; said shaft is positionable in a proximal operative orientationcausing said cutting tooth to assume said closed retracted position; andsaid shaft causing said cutting tooth to assume said open extendedposition by assuming a distal operative orientation.
 25. A bone materialremoval device according to claim 1, wherein said shaft comprises adistal sloping end; wherein said cutting tooth comprises: a cuttingedge; an angled surface on an opposite side to said cutting edgecorresponding to said sloping end of said shaft; and at least one slotoriented radially to said shaft and configured to slide along at leastone pin fixedly attached to said tubular element, wherein said at leastone slot restricts movement of said cutting tooth to a radial direction;and wherein axial displacement of said shaft urges said sloped distalend to be displaced under said angled surface of said cutting toothbringing said tooth to travel radially and extend beyond an outersurface of the tubular element.